Conditions: Narcolepsy
Keywords: SUVN-G3031 Narcolepsy with and without cataplexy Cataplexy Narcolepsy Type 1 Narcolepsy Type 2 Excessive Daytime Sleepiness (EDS) Histamine H3 receptor Samelisant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 190
Healthy volunteers: no

Brief summary:
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.

Detailed description:
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.

Arms:
arm 1: Orally taken once daily for 14 days arm 2: Orally taken once daily for 14 days arm 3: Orally taken once daily for 14 days

Interventions: intervention 1: SUVN-G3031 intervention 2: Placebo
Intervention descriptions: intervention 1: SUVN-G3031 Tablets intervention 2: Placebo Tablets

Protocol document:
Prot_000.pdf: 
 
 
Clinical Study Protocol 
 
Protocol Title: A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter 
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and 
Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in 
Patients with Narcolepsy with and without Cataplexy 
Protocol Number: CTP2S13031H3  
NCT04072380  
Date: 16 August 2023 






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INVESTIGATOR SIGNATURE PAGE 
Protocol Title: 
A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter 
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and 
Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in 
Patients with Narcolepsy with and without Cataplexy 
Protocol Number: 
CTP2S13031H3 
Confidentiality and Current Good Clinical Practice (GCP)/E6(R2) Compliance Statement) 
• I, the undersigned, have reviewed this protocol, including appendices, and I will conduct 
the study as described in compliance with this protocol (and amendments), GCP, and 
relevant International Council for Harmonisation (ICH) guidelines. 
• I am thoroughly familiar with the appropriate use of the study drug, as described in this 
protocol and any other information provided by Suven Life Sciences including, but not 
limited to, the current Investigator’s Brochure. 
• Once the protocol has been approved by the Institutional Review Board (IRB), I will not 
modify this protocol without obtaining prior approval of Suven Life Sciences and of the 
IRB. I will submit the protocol amendments and/or any informed consent form 
modifications to Suven Life Sciences and the IRB, and approval will be obtained before 
any amendments are implemented. 
• I ensure that all persons or party assisting me with the study are adequately qualified and 
informed about the Suven Life Sciences study drug and of their delegated study-related 
duties and functions as described in the protocol. 
• I ensure that source documents and trial records that include all pertinent observations on 
each of the site’s trial patients will be attributable, legible, contemporaneous, original, 
accurate, and complete.  
• I understand that all information obtained during the conduct of the study with regard to 
the patients’ state of health will be regarded as confidential. No patients’ names will be 
disclosed. All patients will be identified by assigned numbers on all case report forms, 
laboratory samples, or source documents forwarded to the Sponsor. Clinical information 
may be reviewed by the Sponsor or its agents or regulatory agencies. Agreement must be 
obtained from the patient before disclosure of patient information to a third party. 
• Information developed in this clinical study may be disclosed by Suven Life Sciences to 
other clinical Investigators, regulatory agencies, or other health authority or government 
agencies as required. 
<Name> 
<Title> 
Investigator Signature 
Date (DD-Mmm-YYYY) 
Institution 
 


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2 
SYNOPSIS 
Title of Study: 
A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to 
Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 
4 mg SUVN-G3031 Compared to Placebo in Patients with Narcolepsy with and 
without Cataplexy 
Protocol Number: 
CTP2S13031H3 
Investigators/Study Sites: 
Approximately 65 sites in the United States and Canada 
Phase of Development: 
Phase 2 
Objectives: 
Primary objective: To evaluate the effectiveness of SUVN-G3031 compared with 
placebo as measured by the change in total Epworth Sleepiness Scale (ESS) score. 
Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared 
with placebo as measured by an improvement in the Clinical Global Impression of 
Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the 
Maintenance of Wakefulness Test (MWT) score. 
Exploratory objectives:  
• To evaluate the effectiveness of SUVN-G3031 compared with placebo as 
measured by an improvement in the MWT score, 
 
 
• To evaluate the change in Clinical Global Impression of Change (CGI-C) 
score with regard to EDS 
• To evaluate the change in CGI-S score with regard to EDS 
• To evaluate the change in Patient Global Impression – Change (PGI-C) 
score 
• To evaluate the change in Daily Sleep Diary 
• To evaluate the change in nocturnal overnight polysomnography (PSG) 
assessments 
• To evaluate the change in total ESS score  
Study Endpoints: 
Primary endpoint: Change from baseline in the mean total ESS score at Day 14 
Secondary endpoints:  
• Change from baseline in the mean CGI-S score related to EDS at Day 14 
• Change from baseline in the mean MWT score at Day 14 
Safety endpoints: 
• Physical examination 
• Vital signs 
• Laboratory assessments (blood and urine) 
• Electrocardiogram (ECG) 
• Adverse events (AEs) 
• Adverse events of Special Interest (AESIs) 
• Columbia Suicide Severity Rating Scale (CSSRS) 
Exploratory endpoints:  
• Change from baseline in the mean total ESS score at Day 7 
• Change in MWT score, within each of the 4 MWT sessions within a single 
day (Day 7 and Day 14) 
• Proportion of patients reporting CGI-C scores of 1 or 2 at Day 14 (EDS) 
• Proportion of patients reporting CGI-S scores related to EDS of 1 or 2 at 
Day 7 and Day 14 


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• Proportion of patients with improvement in the PGI-C score from baseline to 
Day 7 and Day 14 
• Change from baseline in the behavior of sleep diary parameters at Day 7 and 
Day 14 (7-day average) 
• Change from baseline in the mean CGI-S score related to EDS at Day 7 
• Changes in the behavior of the nocturnal overnight PSG assessments at 
Day 7 and Day 14 
• Change from baseline in the mean MWT score at Day 7 
• Analysis of all endpoints (except sleep diary parameters and nocturnal 
overnight PSG assessments) evaluating SUVN-G3031 2 mg or 4 mg 
compared with placebo 
• Additional exploratory endpoints may be included in the statistical analysis 
plan (SAP) 
Study Design: 
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter 
study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of 
2 mg and 4 mg SUVN-G3031 compared with placebo in patients with narcolepsy 
with and without cataplexy. Patients will be randomized at a ratio of 1:1:1 to 2 mg 
SUVN-G3031, 4 mg SUVN-G3031, or placebo. Patients will be stratified by at 
least 30% each based on whether they have narcolepsy with or without cataplexy 
(Na-1 or Na-2, respectively). 
Each patient will receive study drug once daily, in a tablet formulation, for 
14 days. Enough patients will be screened to enable 114 patients to be enrolled 
(38 per treatment group). A single, unblinded, interim analysis will be undertaken 
when approximately 50% of patients have completed 14 days of treatment; this 
analysis will enable sample size re-estimation to occur if appropriate. A maximum 
of 57 additional patients (19 patients per treatment arm) will be enrolled to 
generate a total maximum study population of 171 patients. 
Patients, who have provided written informed consent, will be screened up to 
28 days prior to enrollment. Eligible patients will complete a washout period of 
≥ 14 days for all agents targeting cataplexy and ≥ 7 days for all stimulants 
targeting EDS.  
Sleep diaries will be distributed to eligible patients during the screening window 
and patients will start to record their sleep evaluations in it immediately. Diary 
entries will be reviewed at baseline and all subsequent visits. 
Once these washout periods have been completed patients will attend the clinic 
for randomization and baseline (Day 0) assessments; patients will provide a blood 
sample for analysis of plasma PK. After completion of baseline assessments, 
study drug will be dispensed to patients and they will take their first dose the next 
day (Day 1); patients will receive enough study drug to last until the next visit at 
Day 7. On Day 7 (±1 day) patients will attend the clinic for an outpatient visit, 
when efficacy and safety assessments will be undertaken. Patients will provide a 
blood sample for PK analysis at the estimated trough (just prior to dosing) and at 
the estimated maximum plasma concentration of SUVN-G3031 (3 ± 0.5 hours 
postdosing). Patients will be dispensed enough study drug to last until the next 
visit at Day 14. On Day 14 (±1 day) patients will attend the clinic for an 
outpatient visit, where efficacy and safety assessments will be undertaken. They 
will provide a sample for PK analysis as per the Day 7 visit. 
A final safety follow-up visit will be performed at Day 21 (±1 day). All visits will 
be outpatient visits and patients will be enrolled in the study for a maximum of 
49 days (7 weeks). 


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Selection of Patients: 
Inclusion Criteria: 
1. Must be between the ages of 18 to 65 years, inclusive. 
2. Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the 
International Classification of Sleep Disorders (3rd Edition) criteria for the 
diagnosis of narcolepsy (new or previously diagnosed). 
3. Have undergone a Multiple Sleep Latency Test (MSLT) study showing an 
MSLT of ≤ 8 minutes with 2 or more sleep onset rapid eye movement periods 
(SOREMPs) performed according to standard techniques, with substitution of 
1 of the required SOREMPs on MSLT with 1 obtained from the preceding 
nocturnal PSG, performed at the time of diagnosis. No other potential cause for 
EDS must have been identified during the preceding nocturnal PSG. If the 
study site is unable to obtain the MSLT diagnoses, the MSLT may be 
performed to confirm diagnoses upon Sponsor and medical monitor approval. 
4. An ESS score of ≥ 12; and mean MWT time of < 12 minutes across the first 
4 sessions at baseline. An ESS score of ≥ 12 for eligibility is only required at 
the Baseline visit. An ESS score of < 12 at Screening due to concomitant 
medications will be subjected to PI’s discretion for eligibility. 
5. Must have a body mass index ranging from 18 to < 45 kg/m2. 
6. Negative urine drug screen (UDS) at the Screening and Baseline (Visit 1) 
visits.  
• 
A positive UDS at Screening can be repeated up to Day -1; however, a 
negative UDS is required prior to Day 0 (Baseline visit), and a second 
negative UDS is required on Day 0 (Baseline visit). 
• 
A positive UDS at Screening due to concomitant medications will be 
subject to PI’s discretion for eligibility. 
7. All patients must agree to remain free of alcohol and illicit drugs from 
Screening and until the Safety Follow-up visit. 
8. All male patients who are sexually active and not surgically sterilized must 
agree to use a condom with or without spermicide, in addition to any birth 
control used by their partner during the study until 1 month after the final dose 
of investigational product (IP).  
9. Before randomization, a woman must be either not of childbearing potential or 
of childbearing potential practicing highly effective methods of birth control. 
• 
“Not of childbearing potential” is defined as a patient who is 
postmenopausal (> 45 years of age with amenorrhea for at least 
12 months); permanently sterilized (e.g., tubal occlusion, hysterectomy, 
bilateral salpingectomy); or otherwise is incapable of pregnancy (due to 
reasons including bilateral blocked fallopian tubes, bilateral oophorectomy, 
androgen insensitivity syndrome, and Müllerian agenesis). 
• 
“Of childbearing potential” and practicing a highly effective method of 
birth control is defined as a patient following regulations consistent with 
the use of birth control methods for patients participating in clinical 
studies. A highly effective method of birth control is a method with low 
user dependency that results in a low failure rate (i.e., less than 1% per 
year) when used consistently and correctly. Nonexhaustive examples of 
highly effective methods include: e.g., established use of oral, injected, or 
implanted hormonal methods of contraception; placement of an 
intrauterine device or intrauterine system; barrier methods: condom with 
spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm 
or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; 
male partner sterilization (the vasectomized partner should be the sole 
partner for that patient), or male partner is using condoms with spermicide; 


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practicing true abstinence (the preferred and usual lifestyle of the patient). 
Two forms of effective methods of birth control must be used during the 
study and for 1 month after the last dose of IP. 
10. Willingness to complete the study protocol with full compliance with 
procedures and sign an informed consent form. 
Exclusion Criteria: 
1. 
Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time 
of < 6 h and habitual bedtime past 1 AM as determined by sleep diary entries. 
2. Use of any investigational therapy within the 30-day period prior to enrollment. 
3. Excessive caffeine (defined as > 600 mg/per day) use at least 1week prior to 
baseline assessments and during the course of the trial.  
4. Nicotine dependence that has an effect on sleep (e.g., a patient who routinely 
awakens at night to smoke). 
5. Use of concurrent medications prescribed to treat narcolepsy or any 
indication as specified including stimulants, antidepressants and sodium 
oxybate before Baseline and until the Safety Follow-up visit. 
6. Current diagnosis of or past treatment for syndromes known to cause sleep 
disruption or any other cause of daytime sleepiness. If Investigator confirms 
that any of the following syndromes are not clinically significant to the extent 
that it is causing sleep disturbance, this patient may be permitted at the 
Investigator’s discretion. 
• 
Obstructive sleep apnea, or individuals requiring continuous positive 
airway pressure (obstructive sleep apnea noted during nocturnal PSG 
should be queried).  
• 
Periodic limb movement disorder (periodic limb movements noted 
during nocturnal PSG should be queried). 
• 
Other clinically significant disorders which cause sleep disruption (e.g., 
chronic pain disorder, chronic or untreated insomnia, clinically 
significant levels of gastroesophageal reflux disease, asthma, neuropathy, 
or other chronic pain disorders such as osteoarthritis or degenerative joint 
disease). 
• 
Hypothyroidism requires Investigator assessment to determine whether it 
contributes to interrupted or poor sleep, (i.e., causing daytime somnolence). 
• 
Parasomnias. 
• 
Significant nocturia. 
7. Clinically significant ECG abnormalities. Patients are excluded with a 
screening ECG PR interval of ≥ 300 msec, QRS interval ≥ 200 msec, or 
Fridericia's correction of QT interval ≥ 450 msec for men and ≥ 470 msec for 
women obtained after 3-minute rest in a supine position using a digital ECG. 
Abnormal results for ECGs should be repeated once at screening with 
3 consecutive ECG recordings to ensure reproducibility of the abnormality 
before excluding a subject based on the exclusion criteria. Each ECG 
recording should be taken approximately 5 minutes apart (the ECG result 
reported would be evaluated at each time point). A subject will be excluded if 
the QTcF is ≥450 msec in men and ≥470 msec in women for 2 of the 3 time 
points of the ECGs done, unless due to ventricular pacing. If only 1 ECG 
time point has a QTcF of ≥450 msec in men and ≥470 msec in women, and 
this is not reproduced at either of the other 2 time points, the subject can be 
included in the trial. 
8. Concurrent use of sedating agents such as hypnotics, tranquilizers, sedating 
antihistamines, antipsychotics, benzodiazepines, anticonvulsants, clonidine or 


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tricyclic antidepressants which have H1-antihistamine properties 
(clomipramine, protriptyline) before Baseline and until the Safety Follow-up 
visit.  
9. History of (within past 3 months) or current substance use disorder involving 
illicit drugs, alcohol, or marijuana, as per Diagnostic and Statistical Manual 
of Mental Disorders (DSM-5) criteria and non-disordered use of alcohol and 
recreational drugs. 
10. History or presence of any unstable medical condition or neurological 
disorder which may affect the patient’s safety or stability (such as serious 
cardiovascular disorder, moderate or severe gastrointestinal abnormalities, 
hepatic disorder or renal abnormalities, hepatitis C, hepatitis B, human 
immunodeficiency virus positive status, history of epilepsy, significant head 
injury, history of intracranial surgery, or malignancy in past 5 years).  
11. Patients with preplanned surgeries requiring general anesthesia throughout 
the duration of the trial. 
12. Severe, unstable psychiatric illness including a diagnosis of bipolar disorder, 
schizophrenia or psychotic disorder in the patient’s lifetime, according to 
DSM-5 criteria. Patients with severe or uncontrolled depression that, in the 
judgment of the Investigator, makes the patient inappropriate for entry into the 
study or which will require new onset of treatment during the course of the 
trial. Subjects who are at significant potential suicidal risk are determined by: 
• 
Patients who answer “Yes” on the CSSRS Suicidal Ideation Item 4 (active 
suicidal ideation with some intent to act, without specific plan) and whose 
most recent episode meeting criteria for this CSSRS Item 4 occurred within 
the last 6 months; or 
• 
Patients who answer “Yes” on the CSSRS Suicidal Ideation Item 5 
(active suicidal ideation with specific plan and intent) and whose most 
recent episode meeting criteria for this CSSRS Item 5 occurred within 
the last 6 months; or 
• 
Patients who answer “Yes” on any of the 5 CSSRS Suicidal Behavior 
Items (actual attempt, interrupted attempt, aborted attempt, preparatory 
acts, or behavior) and whose most recent episode meeting criteria for any 
of these 5 CSSRS Suicidal Behavior Items occurred within the last 
2 years; or 
• 
Patients who, in the opinion of the Investigator, present a serious risk of 
suicide. 
13. An occupation requiring variable shift work, night shifts, or frequent 
overnight travel which disrupts sleep patterns. 
14. In the opinion of the Investigator, it would be unsafe for a patient to stop 
taking any wake promoting agent for more than 4 weeks. The patient’s 
occupation (e.g., requirement for driving) may need to be considered. 
Withdrawal Criteria: 
• 
Unacceptable toxicity or AE. 
• 
Clinically significant abnormal lab values: 
o 
Alanine aminotransferase (ALT) or aspartate aminotransferase 
(AST) ≥ 8x upper limit of normal (ULN);  
o 
ALT or AST ≥ 3x ULN and total bilirubin ≥ 2x ULN at the 
same visit;  
o 
ALT or AST ≥ 3x ULN with the appearance of symptoms 
indicating hepatitis (e.g., worsening fatigue, nausea, vomiting, 
right upper quadrant pain or tenderness, fever, rash, or 
eosinophilia).  


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• 
QT syndrome, Fridericia’s formula corrected QT (QTcF) interval 
≥ 470 ms (for male subjects) or ≥ 480 ms (for female subjects), or 
torsades de pointes. 
• 
A positive urinary drug screen at any visit. 
• 
Patient withdrawal of consent: at any time, a patient’s participation in the 
study may be terminated at his/her request or on the basis of the 
Investigator’s clinical judgment. The reason for patient withdrawal will 
be noted on the electronic case report form (eCRF). 
• 
Intercurrent illness: a condition, injury, or disease unrelated to the 
primary diagnosis that became apparent during treatment and 
necessitated the patient’s termination from the study. 
• 
General or specific changes in the patient’s condition that renders 
him/her ineligible for further treatment according to the 
inclusion/exclusion criteria. 
• 
Patient fails to adhere to the protocol requirements (e.g., drug 
noncompliance, failure to return for defined number of visits). 
• 
Lost to follow-up: the patient stopped coming for visits, and study 
personnel were unable to contact the patient. 
• 
Pregnancy. 
Planned Sample Size: 
114 patients (38 per treatment group). This may be increased following a sample 
size re-estimation up to a maximum of 171 patients. 
Investigational Therapy: 
• 
2 mg SUVN-G3031 
• 
4 mg SUVN-G3031 
Reference Therapy: 
Placebo 
Treatment Duration: 
Each patient will be dosed for 14 days. The study is expected to last a total of 
13 months. 
Efficacy: 
Efficacy assessments include MWT, CGI-S, ESS, CGI-C, PGI-C, nocturnal 
overnight PSG, and sleep diary. 
Safety: 
Safety assessments include vital signs, physical examinations, ECGs, laboratory 
assessments, CSSRS and AEs. 
Pharmacokinetics: 
Blood samples will be collected for analysis of plasma PK. 
Statistical Methods and 
Planned Analyses: 
Summary tables will be organized by treatment group. Descriptive statistics for 
continuous variables will include number of patients (n), mean, standard 
deviation, standard error of mean, median, minimum, and maximum, unless 
otherwise noted. Frequency and percentage will be calculated for categorical 
variables. Unless stated otherwise, all summary tables will present descriptive 
statistics and/or frequencies by study part and treatment. All data listings will be 
sorted by treatment and patient number. All data collected during the study will be 
analyzed and reported unless stated otherwise. 
The intent-to-treat (ITT) population will include all patients who were 
randomized, received at least one dose of study drug, and had baseline and at least 
one post-baseline primary efficacy assessment.  
The Safety population will include all randomized patients who receive at least 
1 dose of study treatment. This population will be used for the analysis of safety. 
The Per Protocol (PP) population will be a subset of ITT population consisting of 
those patients who complete 14 days treatment and had no major protocol 
deviation affecting the primary efficacy variable. All protocol deviations will be 
assessed and documented on a case-by-case basis before the database lock, and 
deviations considered to have a serious impact on the efficacy results will lead to 
the relevant patient being excluded from the PP set. Before database lock, 




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3 
TABLE OF CONTENTS 
1 
FINAL CLINICAL STUDY PROTOCOL ...................................................................1 
2 
SYNOPSIS ........................................................................................................................4 
3 
TABLE OF CONTENTS ..............................................................................................11 
3.1 
List of In-text Tables ..................................................................................................15 
3.2 
List of In-text Figures .................................................................................................15 
4 
LIST OF ABBREVIATIONS .......................................................................................16 
5 
INTRODUCTION .........................................................................................................18 
5.1 
Background on Narcolepsy ........................................................................................18 
5.2 
Background on SUVN-G3031 ...................................................................................19 
5.2.1 
Nonclinical Studies ............................................................................................20 
5.2.2 
Clinical Studies ..................................................................................................20 
5.3 
Clinical Risks/Benefits of SUVN-G3031 ...................................................................21 
5.3.1 
Risks ...................................................................................................................21 
5.3.2 
Benefits ..............................................................................................................21 
5.4 
Study Rationale ..........................................................................................................21 
6 
STUDY OBJECTIVES AND ENDPOINTS ...............................................................23 
6.1 
Study Objectives .........................................................................................................23 
6.1.1 
Primary Objective ..............................................................................................23 
6.1.2 
Secondary Objectives .........................................................................................23 
6.1.3 
Exploratory Objectives ......................................................................................23 
6.2 
Study Endpoints..........................................................................................................23 
6.2.1 
Primary Endpoint ...............................................................................................23 
6.2.2 
Secondary Endpoints ..........................................................................................23 
6.2.3 
Safety Endpoints ................................................................................................23 
6.2.4 
Exploratory Endpoints .......................................................................................24 
7 
INVESTIGATIONAL PLAN .......................................................................................25 
7.1 
Description of Overall Study Design and Plan ...........................................................25 
7.1.1 
Screening ............................................................................................................26 
7.1.2 
Dosing Period .....................................................................................................26 
7.1.3 
Safety Follow-up ................................................................................................26 
7.1.4 
Data Monitoring Committee ..............................................................................26 


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7.2 
Discussion of Study Design........................................................................................26 
7.2.1 
Eligibility Criteria ..............................................................................................26 
7.2.2 
Assessments .......................................................................................................27 
7.2.2.1 
Primary Outcome Measure ...........................................................................27 
7.2.2.2 
Secondary Outcome Measures .....................................................................28 
7.2.2.3 
Exploratory Outcome Measures ...................................................................30 
7.3 
End of Study ...............................................................................................................34 
8 
SELECTION OF STUDY POPULATION .................................................................35 
8.1 
Inclusion Criteria ........................................................................................................35 
8.2 
Exclusion Criteria .......................................................................................................36 
8.3 
Rescreening ................................................................................................................38 
8.4 
Study Withdrawal, Removal, and Replacement of Patients .......................................38 
9 
TREATMENTS .............................................................................................................41 
9.1 
Details of Study Treatments .......................................................................................41 
9.2 
Dosage Schedule ........................................................................................................41 
9.3 
Measures to Minimize Bias: Study Treatment Assignment and Blinding .................41 
9.3.1 
Method of Study Treatment Assignment ...........................................................41 
9.3.2 
Blinding ..............................................................................................................41 
9.4 
Dosage Modification ..................................................................................................42 
9.5 
Treatment Accountability and Compliance ................................................................42 
9.6 
Prior and Concomitant Therapy .................................................................................43 
9.6.1 
Prior and Concomitant Medications ..................................................................43 
10 
STUDY PROCEDURES ...............................................................................................44 
10.1 Informed Consent .......................................................................................................48 
10.2 Study Procedures ........................................................................................................48 
10.2.1 
Assessment Order ..............................................................................................48 
11 
EFFICACY ASSESSMENTS .......................................................................................50 
11.1 Maintenance of Wakefulness Test ..............................................................................50 
11.2 Clinical Global Impression of Severity ......................................................................50 
11.3 Epworth Sleepiness Scale ...........................................................................................50 
11.4 Clinical Global Impression of Change .......................................................................51 
11.5 Patient Global Impression of Change .........................................................................51 
11.6 Nocturnal Overnight Polysomnography .....................................................................51 
11.7 Sleep Diary .................................................................................................................52 


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12 
SAFETY ASSESSMENTS ............................................................................................53 
12.1 Medical History and Disease History .........................................................................53 
12.2 Vital Signs ..................................................................................................................53 
12.3 Physical Examination .................................................................................................53 
12.4 Electrocardiograms .....................................................................................................54 
12.5 Laboratory Assessments .............................................................................................54 
12.6 Columbia Suicide Severity Rating Scale ....................................................................55 
12.7 Adverse Events ...........................................................................................................56 
12.7.1 
Adverse Events ..................................................................................................56 
12.7.2 
Adverse Events of Special Interest ....................................................................57 
12.7.3 
Serious Adverse Events .....................................................................................57 
12.7.4 
Serious Adverse Event Reporting ......................................................................58 
12.7.5 
Suspected Unexpected Serious Adverse Reactions ...........................................59 
12.7.6 
Pregnancy ...........................................................................................................59 
12.7.7 
Overdose ............................................................................................................60 
13 
PHARMACOKINETICS ..............................................................................................61 
13.1 Pharmacokinetic Sampling .........................................................................................61 
13.1.1 
Blood Samples ...................................................................................................61 
13.2 Pharmacokinetic Analytical Methodology .................................................................61 
14 
STATISTICAL ANALYSIS .........................................................................................62 
14.1 Determination of Sample Size ....................................................................................62 
14.2 Analysis Populations ..................................................................................................62 
14.3 Efficacy Analysis........................................................................................................63 
14.3.1 
Analysis of Primary Efficacy Endpoint .............................................................63 
14.3.2 
Analysis of Secondary Efficacy Endpoints ........................................................64 
14.3.3 
Analysis of Exploratory Endpoints ....................................................................64 
14.4 Safety Analysis ...........................................................................................................65 
14.4.1 
Adverse Events ..................................................................................................65 
14.4.2 
Laboratory Evaluations ......................................................................................65 
14.4.3 
Vital Signs ..........................................................................................................65 
14.4.4 
Electrocardiogram ..............................................................................................66 
14.4.5 
Prior and Concomitant Medications ..................................................................66 
14.4.6 
Physical Examination .........................................................................................66 
14.4.7 
Columbia Suicide Severity Rating Scale ...........................................................66 


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14.4.8 
Patient Disposition .............................................................................................66 
14.4.9 
Demographic and Baseline Characteristics ........................................................66 
14.5 Pharmacokinetic Analysis ..........................................................................................66 
14.6 Interim Analysis .........................................................................................................66 
14.7 Data Monitoring Committee .......................................................................................67 
15 
STUDY MANAGEMENT ............................................................................................68 
15.1 Approval and Consent ................................................................................................68 
15.1.1 
Regulatory Guidelines ........................................................................................68 
15.1.2 
Institutional Review Board ................................................................................68 
15.1.3 
Informed Consent ...............................................................................................68 
15.2 Data Handling .............................................................................................................68 
15.3 Source Documents ......................................................................................................69 
15.4 Record Retention ........................................................................................................69 
15.5 Monitoring ..................................................................................................................69 
15.6 Quality Control and Quality Assurance .....................................................................70 
15.7 Protocol Amendment and Protocol Deviation ............................................................70 
15.7.1 
Protocol Amendment .........................................................................................70 
15.7.2 
Protocol Deviations ............................................................................................70 
15.8 Ethical Considerations ................................................................................................70 
15.9 Financing and Insurance .............................................................................................71 
15.10 Publication Policy/Disclosure of Data........................................................................71 
16 
REFERENCES ..............................................................................................................72 
17 
APPENDICES ................................................................................................................75 
Appendix 1. 
Contraception Guidelines .............................................................................76 
Appendix 2. 
Prohibited or Restricted Medications ...........................................................77 
Appendix 3. 
Caffeine Dosages for Common Drinks ........................................................78 
 


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3.1 
List of In-text Tables 
Table 1. Schedule of Assessments ........................................................................................45 
Table 2. Laboratory Assessments..........................................................................................55 
Table 3. Classification of Adverse Events by Intensity ........................................................56 
Table 4. Classification of Adverse Events by Relationship to Study Drug ..........................57 
 
3.2 
List of In-text Figures 
Figure 1. Study Design ...........................................................................................................25 
 
 


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4 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
CFR 
Code of Federal Regulations 
CGI-C 
Clinical Global Impression of Change 
CGI-S 
Clinical Global Impression of Severity 
CSD 
Consensus Sleep Diary 
CSF 
cerebrospinal fluid 
CSSRS 
Columbia Suicide Severity Rating Scale 
DMC 
data monitoring committee 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EDS 
excessive daytime sleepiness 
ESS 
Epworth Sleepiness Scale 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
H3R 
histamine H3 receptor 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IP 
investigational product 
IRB 
institutional review board 
IRT 
interactive response technology 
ITT 
intent-to-treat 
MMRM 
mixed model repeated measures 
MSLT 
Multiple Sleep Latency Test 
MWT 
Maintenance of Wakefulness Test 
Na-1 
narcolepsy with cataplexy 
Na-2 
narcolepsy without cataplexy 
PGI 
Patient Global Impression 
PGI-C 
Patient Global Impression - Change 
PI 
Principal Investigator 
PK 
pharmacokinetic(s) 
PO 
oral 
PP 
per protocol 


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Abbreviation 
Definition 
PSG 
polysomnography 
REM 
rapid eye movement 
RT 
reaction time 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SD 
standard deviation 
SOL 
sleep onset latency 
SOREMP 
sleep onset rapid eye movement period 
SUSAR 
suspected unexpected serious adverse reaction 
TEAE 
treatment-emergent adverse event 
UDS 
urine drug screen 
ULN 
upper limit of normal 
US 
United States 
WASO 
wake after sleep onset 
WOCBP 
women of childbearing potential 
 


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5 
INTRODUCTION 
5.1 
Background on Narcolepsy 
Narcolepsy is a long-term neurological disorder that specifically affects the regulation of 
sleep-wake cycles. The disorder affects males and females equally with symptoms often starting 
in childhood, adolescence, or young adulthood (ages 7 to 25 years). It is estimated that anywhere 
from 135,000 to 200,000 people in the United States (US) have narcolepsy 
[National Institute of Neurological Disorders and Stroke, 2018]; however, because the condition 
often goes undiagnosed, the prevalence could be higher. People with narcolepsy are often 
misdiagnosed with other conditions, such as psychiatric disorders or medical disorders, delaying 
proper diagnosis and treatment for years. 
The cardinal symptom of narcolepsy is excessive daytime sleepiness (EDS) [Nishino, 2007]. 
Excessive daytime sleepiness is characterized by persistent sleepiness, regardless of nighttime 
sleep accrual, and is often described as a “sleep attack” where patients experience a sudden and 
overwhelming sense of sleepiness [National Institute of Neurological Disorders and Stroke, 2018]. 
In between sleep attacks, however, patients with narcolepsy experience normal levels of alertness.  
Narcolepsy may be further defined by the presence or absence of cataplexy. Approximately 70% 
of patients with narcolepsy experience cataplexy characterized by recurrent episodes of sudden 
loss of muscle strength accompanied by full conscious awareness [Wozniak and Quinell, 2015]. 
Narcolepsy with cataplexy (narcolepsy-cataplexy; hypocretin deficiency syndrome) is referred to 
as Narcolepsy Type 1 (Na-1). Cataplexy attacks in patients with Na-1 are typically triggered by 
negative and positive emotions [Calik, 2017] and vary in frequency, character, and severity. 
Severe attacks can result in a total body collapse during which patients are unable to move, 
speak, or keep their eyes open [National Institute of Health, 2017]. Narcolepsy without cataplexy 
is referred to as Narcolepsy Type 2 (Na-2).  
Additional symptoms of narcolepsy experienced in both patients with Na-1 and patients with 
Na-2 at differing intensities and frequencies include hypnagogic hallucinations, sleep paralysis, 
and automatic behavior [Sturzenegger and Bassetti, 2004]. All symptoms of narcolepsy result in 
a decreased quality of life compared with the general population [Bogan et al, 2016]. A 
biological substrate has been suggested in that Na-1 is caused by a deficiency of hypothalamic 
hypocretin (levels ≤ 110 pg/mL). Little is known about the underlying causes of Na-2 
[Baumann et al,2014]. However, evidence from animal models indicates that deficient orexin 
transmission is involved in the Na-2 pathophysiology. Lack of orexin could be circumvented by 
activating histaminergic neurons. 
Until recently, therapy for narcolepsy consisted primarily of amphetamines and related 
stimulants, including methylphenidate and dextroamphetamine, to increase alertness and 
improve daytime performance [Zwicker, 1995; Smith et al, 2016]. Although studies show a 
moderate improvement in alertness levels (to approximately 70% of normal individuals), 
common adverse effects including headaches, nervousness, irritability, tremor, insomnia, 


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anorexia, and palpitations, limit utility of these therapies. Additionally, tolerance to the alerting 
effect of these drugs develops in up to 30% of patients using these medications 
[Mitler et al, 1994]. 
The standard of care for the treatment of EDS in patients with narcolepsy is modafinil or its 
enantiomer, armodafinil (although a number of products generally subsumed under the category 
of “stimulants” are available) [Billiard, 2008]. Chemically distinct and to some extent 
pharmacologically unrelated to other stimulants, modafinil has an improved safety profile and 
lower abuse potential, compared with older stimulants; however, it usually does not reduce EDS 
to normal levels [Wise et al, 2007] and provides no benefit for cataplexy or disrupted nighttime 
sleep, necessitating the use of other drugs for these symptoms. For cataplexy, venlafaxine, 
fluoxetine, clomipramine, and sodium oxybate customarily are employed. 
In 2002, sodium oxybate was approved by the US Food and Drug Administration for the 
treatment of cataplexy and EDS in adults with narcolepsy (Xyrem®, Jazz Pharmaceuticals plc.). 
Although the drug has advantages over previously used cataplexy therapies in that it targets both 
EDS and cataplexy, it requires titration to an optimal dose, and must be administered under a 
Risk Evaluation and Mitigation Strategies mandate in the United States through a central 
pharmacy in conjunction with step therapy. Co-administration of sodium oxybate with modafinil 
was shown to provide improved beneficial effects on EDS compared with the administration of 
either medication alone, as might be anticipated by the mechanisms of action for each agent 
[Black and Houghton, 2006]. However, a single safe and effective therapeutic agent for the 
treatment of multiple symptoms is still unavailable and would represent a significant 
advancement in treatment options.  
To address this unmet need, Suven is developing SUVN-G3031, an orally active inverse agonist 
of the human histamine H3 receptors (H3R). Histaminergic neurons are mainly located in the 
posterior hypothalamus and play a role in arousal mechanisms. It has been demonstrated that the 
H3R inverse agonists are able to promote activation of cerebral histamine neurons. 
SUVN-G3031 enhances the histaminergic transmissions in brain, acetylcholine release in 
prefrontal cortex and hippocampus, and dopamine release in prefrontal cortex (but not in 
striatum and nucleus accumbens). 
5.2 
Background on SUVN-G3031 
SUVN-G3031 emerges as a potent, selective, orally bioavailable, brain-penetrating, H3R-inverse 
agonist with dose-dependent receptor occupancy implicated in the regulation of sleep/wake 
cycles. SUVN-G3031 increased wakefulness in rodents providing the evidence for treatment of 
sleep-related disorders. In rodent models of cognition, a procognitive effect has been 
demonstrated and SUVN-G3031 enhanced neurotransmitters responsible for procognitive 
properties. In wild type and orexin knockout mice, the selective H3R antagonist GSK189254 
increased wakefulness, and decreased slow wave sleep and paradoxical sleep, supporting the 
potential use of H3R antagonist/inverse agonist for the treatment of narcolepsy in EDS 
[Guo et al, 2009]. 


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5.2.1 
Nonclinical Studies 
Six-month oral toxicity studies of SUVN-G3031 in rats, and 9-month oral toxicity studies in 
dogs have been completed along with genotoxicity, fertility studies in rats, and fetal development 
toxicity studies in rat and rabbit embryo. Overall, the single-dose, repeat-dose, genotoxicity and 
reproduction and developmental toxicity studies completed support conduct of the 
Investigational New Drug Phase 2 study in patients with narcolepsy at the dosage levels and 
durations of exposures proposed. Clinical observations, within in vivo models reported, are 
related to the pharmacological effects of this class of compound. These observations, as well as 
those obtained from regulatory mandated evaluations of safety (cardiovascular, respiratory, and 
central nervous system) suggest standard methods of surveillance are sufficient at dosage levels 
proposed for clinical use. 
Further information on nonclinical studies can be found in the Investigator’s Brochure. 
5.2.2 
Clinical Studies 
The SUVN-G3031 Phase 1 program included 72 healthy volunteers and provided preliminary 
clinical safety and pharmacokinetic (PK) data. SUVN-G3031 was well tolerated in both 
single-dose (up to 20 mg oral [PO]) and multiple-dose administrations (up to 6 mg PO for 
14 days). There were no deaths, serious adverse events (SAEs), or treatment-emergent adverse 
events (TEAEs) leading to discontinuation from the Phase 1 program. The most frequently 
reported TEAE preferred terms were dyssomnia (33.3%) followed by abnormal dreams (27.8%), 
and TEAEs that occurred most frequently were in the System Organ Class, Psychiatric 
Disorders. 
A maximum tolerated single dose (20 mg PO) and maximally well tolerated multiple doses of 
6 mg/day PO for 14 days were established using a sequential dose-escalation paradigm. 
Specifically, no significant changes in safety parameters including laboratory results, physical 
examinations, vital signs, fluid balance, suicidal ideation, and electrocardiogram (ECG) 
parameters were noted. Pharmacokinetic data suggest dose proportionality across a range from 
0.1 mg to 20 mg after single administration of SUVN-G3031 PO, with the main terminal 
half-life of approximately 23 to 34 hours across dosages evaluated. Multiple oral administration 
exhibited dose-proportional increases in exposures across 1 mg to 6 mg dose range with steady 
state achieved in approximately 5 days. Approximately 55% to 60% of the administered dose 
was excreted via the urinary route. Food, gender, and age had no appreciable effect on the PK 
profile of SUVN-G3031. 
SUVN-G3031 may be used adjunctively with a variety of compounds affecting EDS or 
cataplexy in patients with narcolepsy as outlined in the Investigator’s Brochure. However, 
SUVN-G3031 is being evaluated as a monotherapy in the current protocol and all adjunctively 
used compounds affecting EDS or cataplexy in patients with narcolepsy are prohibited.  
Further information on clinical studies can be found in the Investigator’s Brochure. 


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5.3 
Clinical Risks/Benefits of SUVN-G3031 
5.3.1 
Risks 
This is the first study to be performed using SUVN-G3031 in patients with narcolepsy. As such 
there may be risks to the enrolled patients that cannot be identified at this stage. 
Based on clinical trials in healthy subjects, there are no expected adverse reactions. The most 
frequently reported TEAE preferred terms in healthy subject trials were dyssomnia (33.3%) 
followed by abnormal dreams (27.8%), and the TEAEs that occurred most frequently were in the 
System Organ Class, Psychiatric Disorders. 
5.3.2 
Benefits 
Due to the short treatment period in this study (14 days), patients are unlikely to experience any 
benefit from enrollment in this study. However, results from this study will be used to advance 
the development of SUVN-G3031; therefore, potentially benefitting this population in the future. 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 


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6 
STUDY OBJECTIVES AND ENDPOINTS 
6.1 
Study Objectives 
6.1.1 
Primary Objective 
To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by the 
change in total Epworth Sleepiness Scale (ESS) score. 
6.1.2 
Secondary Objectives 
To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an 
improvement in the Clinical Global Impression of Severity (CGI-S) score related to EDS and the 
Maintenance of Wakefulness Test (MWT) score. 
6.1.3 
Exploratory Objectives 
• To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an 
improvement in the MWT score, 
 
• To evaluate the change in Clinical Global Impression of Change (CGI-C) score with 
regard to EDS 
• To evaluate the change in CGI-S score with regard to EDS 
• To evaluate the change in Patient Global Impression – Change (PGI-C) score 
• To evaluate the change in Daily Sleep Diary 
• To evaluate the change in nocturnal overnight polysomnography (PSG) assessments 
• To evaluate the change in total ESS score  
6.2 
Study Endpoints 
6.2.1 
Primary Endpoint 
The primary endpoint of this study is the change from baseline in the mean total ESS score at 
Day 14. 
6.2.2 
Secondary Endpoints 
The secondary endpoints in this study are as follows: 
• Change from baseline in the mean CGI-S score related to EDS at Day 14 
• Change from baseline in the mean MWT score at Day 14 
6.2.3 
Safety Endpoints 
The safety endpoints in this study are as follows: 
• Physical examination 
• Vital signs 
• Laboratory assessments (blood and urine) 


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• Electrocardiogram 
• Adverse events (AEs) 
• AEs of special interest (AESIs) 
• Columbia Suicide Severity Rating Scale (CSSRS) 
6.2.4 
Exploratory Endpoints 
The exploratory endpoints of this study are as follows: 
• Change from baseline in the mean total ESS score at Day 7 
• Change in MWT score, within each of the 4 MWT sessions within a single day (Day 7 
and Day 14) 
• Proportion of patients reporting CGI-C scores of 1 or 2 at Day 14 (EDS) 
• Proportion of patients reporting CGI-S scores related to EDS of 1 or 2 at Day 7 and 
Day 14 
• Proportion of patients with improvement in the PGI-C score from baseline to Day 7 and 
Day 14 
• Change from baseline in the behavior of sleep diary parameters at Day 7 and Day 14 
(7-day average) 
• Change from baseline in the mean CGI-S score related to EDS at Day 7 
• Changes in the behavior of the nocturnal overnight PSG assessments at Day 7 and 
Day 14 
• Change from baseline in the mean MWT score at Day 7 
• Analysis of all endpoints (except sleep diary parameters and nocturnal overnight PSG 
assessments) evaluating SUVN-G3031 2 mg or 4 mg compared with placebo 
• Additional exploratory endpoints may be included in the statistical analysis plan (SAP) 


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7 
INVESTIGATIONAL PLAN 
7.1 
Description of Overall Study Design and Plan 
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate 
the safety, tolerability, PK, and efficacy of 2 mg and 4 mg SUVN-G3031 compared with placebo 
in patients with narcolepsy with and without cataplexy. Patients will be randomized at a ratio of 
1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Patients will be stratified by at 
least 30% each based on whether they have narcolepsy with or without cataplexy (Na-1 or Na-2, 
respectively). 
Each patient will receive study drug once daily, in a tablet formulation, for 14 days. Sufficient 
patients will be screened to enable 114 patients to be enrolled (38 per treatment group). Further 
details on the sample size calculations can be found in Section 14.1. A single, unblinded, interim 
analysis will be undertaken when approximately 50% of patients have completed 14 days of 
treatment; this analysis will enable sample size re-estimation to occur if appropriate. A maximum 
of 57 additional patients (19 patients per treatment arm) will be enrolled to generate a total 
maximum study population of 171 patients. Further details on the interim analysis can be found 
in Section 14.6. 
Patients will be enrolled at approximately 65 sites in the United States and Canada. It is anticipated 
that it will take 12 months to complete enrollment and 13 months to complete the entire study. 
A study schematic can be seen in Figure 1. 
Figure 1. 
Study Design 
 
Abbreviations: ESS, Epworth Sleepiness Scale; MWT, Maintenance of Wakefulness Test. 
 


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7.1.1 
Screening 
Patients who have provided written informed consent will be screened up to 28 days before 
enrollment. Eligible patients will complete a washout period of ≥ 14 days for all agents targeting 
cataplexy and ≥ 7 days for all stimulants targeting EDS.  
7.1.2 
Dosing Period 
Once these washout periods have been completed, patients will attend the clinic for 
randomization and baseline (Day 0) assessments; patients will provide a blood sample for PK 
analysis. After completion of baseline (Day 0) assessments, study drug will be dispensed to 
patients and they will take their first dose the next day (Day 1); patients will receive enough 
study drug to last until the next visit at Day 7. On Day 7 (±1 day), patients will attend the clinic 
for an outpatient visit, when efficacy and safety assessments will be undertaken. Patients will 
provide a blood sample for PK analysis at the estimated trough (just prior to dosing) and at the 
estimated maximum plasma concentration of SUVN-G3031 (3 ± 0.5 hours postdosing). Patients 
will be dispensed enough study drug to last until the next visit at Day 14. On Day 14 (±1 day), 
patients will attend the clinic for an outpatient visit, where efficacy and safety assessments will 
be undertaken. They will provide a sample for PK analysis as per the Day 7 visit.  
7.1.3 
Safety Follow-up 
A final safety follow-up visit will be performed at Day 21 (±1 day). All visits will be outpatient 
visits and patients will be enrolled in the study for a maximum of 49 days (7 weeks) from the 
start of the screening period. 
7.1.4 
Data Monitoring Committee 
The data monitoring committee (DMC) will be established and the charter, composition, and 
methods of analysis and review will be presented separately prior to study initiation.
 
 
 
 
7.2 
Discussion of Study Design 
7.2.1 
Eligibility Criteria 
The primary objective of this study is to evaluate the impact of SUVN-G3031 on EDS associated 
with narcolepsy in adult patients aged 18 to 65 years. Patients must present with an established 
diagnosis of Na-1 or Na-2 to be considered eligible for enrollment consistent with the American 
Academy of Sleep Medicine, International Classification of Sleep Disorders, 3rd Edition. The 
randomization is not constrained upon subtype, although stratification based upon the diagnosis 
of Na-1 or Na-2 is included. 
As the primary objective of this study is to evaluate the impact of SUVN-G3031 on EDS 
associated with narcolepsy, minimum thresholds of severity of EDS will be required. The 
minimum threshold of severity of EDS will be defined using key eligibility criteria of MWT 


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mean time of < 12 minutes across the first 4 sessions at baseline [Schwartz et al, 2004] and ESS 
score of ≥ 12 [Szakacs et al, 2017]. 
Patients with Na-1 must have a documented history of irrepressible need to sleep or daytime 
lapses into sleep for at least 3 months, and the presence of cataplexy with previously confirmed 
Multiple Sleep Latency Test (MSLT) ≤8 minutes with 2 or more sleep onset rapid eye movement 
periods (SOREMPs) performed according to standard techniques. Substitution of 1 of the 
required SOREMPs on MSLT with 1 obtained from the preceding nocturnal PSG, obtained at the 
time of diagnosis, is permitted. Alternatively, previously obtained cerebrospinal fluid (CSF) 
hypocretin-1 concentrations may also be used to support the diagnosis in the absence of clinical 
cataplexy assuming acceptable MSLT findings [Scammell, 2003]. 
Compliance with a uniform operational definition of cataplexy is not mandated by protocol 
because cataplexy phenotype and frequency may differ widely across patients [Pillen et al, 2017] 
(frequent attacks of collapse, sporadic partial attacks, etc) and because modification of cataplexy 
after pharmacotherapy is not a principal hypothesis of the study. 
Patients with Na-2 must have a comparable history of irrepressible need to sleep or daytime 
lapses into sleep for at least 3 months, identical criteria based upon MSLT and nocturnal PSG, 
but do not have a clinical history of cataplexy or data based upon CSF hypocretin-1 
concentrations which are incompatible with the diagnosis. For both conditions, eligibility criteria 
mimic those frequently associated with interventional studies in narcolepsy and reduce 
diagnostic confounders related to medical condition such as obstructive sleep apnea, and 
psychiatric disorders including chronic fatigue syndrome, depression, bipolar affective disorder, 
malingering, and substance use disorder. Idiopathic hypersomnia must be excluded by the 
pre-existing diagnostic evaluation [Broughton et al, 1997]. 
SUVN-G3031 in this study is being evaluated as a monotherapy; patients will require washout 
from current narcolepsy therapies for both EDS and cataplexy. Washout period will occur within 
a maximum 28-day screening period to allow for minimum drug free period of ≥ 7 days for all 
stimulants targeting EDS, and ≥ 14 days for all agents targeting cataplexy prior to randomization 
and baseline assessments. The 28-day screening period allows a window of drug withdraw to be 
completed safely at the discretion of the Investigator.  
7.2.2 
Assessments 
7.2.2.1 
Primary Outcome Measure 
The primary objective pivots upon changes in EDS in patients with Na-1 and Na-2. The primary 
outcome measure, the change in total ESS scores from baseline, is used to derive the primary 
dependent variable. A successful study requires demonstration of a statistically significant 
difference between treatment groups based upon the ESS as a single primary endpoint, using a 
prespecified analytic model and an intent-to-treat (ITT) dataset. 
The ESS consists of 8 questions chosen on a priori grounds to represent activities with a wide 
range of different somnificities. 


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The ESS is a self-administered questionnaire wherein respondents are asked to rate on a 4-point 
scale (0–3) their usual chances of dozing off or falling asleep while engaged in 8 different 
activities (see Section 11.3). It is important that participants answer every question, as there is no 
method for interpolating item scores and a missed question results in an invalid test. Most people 
engage in the activities in the test at least occasionally, although not necessarily every day. The 
recall period for the test asks subjects to rate experiences taking place “in recent times,” which is 
purposefully vague and is meant to represent a few weeks to a few months. Within the study, the 
ESS will be completed weekly, consistent with the recall period. The ESS score (the sum of 
8 item scores, 0–3) can range from 0 to 24. The higher the ESS score, the higher the person’s 
average sleep propensity in daily life, or their “daytime sleepiness.” The questionnaire takes no 
more than 2 or 3 minutes to answer. The ESS can be interpreted per the bullets below: 
• 0 to 5 Lower Normal Daytime Sleepiness 
• 6 to 10 Higher Normal Daytime Sleepiness 
• 11 to 12 Mild EDS 
• 13 to 15 Moderate EDS 
• 16 to 24 Severe EDS 
In contrast to other sleep scales, the ESS has been designed to use the questions above based on 
subject reports to determine sleep propensity or EDS [Johns, 2000]. As a result, the test can 
measure a subject’s high sleep propensity or history of dozing in situations that are low soporific 
in nature and during which normal subjects would be unlikely to fall asleep [Johns, 2000; 
Herring et al, 2013; Van der Heid et al, 2015; Weaver et al, 2020]. Furthermore, a recent 
publication emphasized that ESS could be a reliable measure to evaluate daytime sleepiness in 
clinical trials with histamine 3 receptor antagonists [Inoue et al, 2022]. Thus, the ESS is a useful 
test to determine improvement in sleep propensity in patients with narcolepsy treated with 
targeted therapeutic agents.  
7.2.2.2 
Secondary Outcome Measures 
The secondary measures include the change from baseline in the clinician-derived CGI-S related 
to EDS [Dauvilliers et al, 2013; Szakacs et al, 2017] and the change in MWT score from 
baseline. Appropriate methods for control of multiplicity will be employed for analysis of 
secondary endpoints (see Section 14.3.2).  
7.2.2.2.1 Clinical Global Impression of Severity 
The CGI was developed for use in National Institute of Mental Health-sponsored clinical studies 
to provide a brief, stand-alone assessment of the clinician’s view of the patient’s global 
functioning prior to and after initiating a study medication. The CGI provides an overall 
clinician-determined summary measure that takes into account all available information, 
including a knowledge of the patient’s history, psychosocial circumstances, symptoms, behavior, 
and the impact of the symptoms on the patient’s ability to function. In all of its applications, it 


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functions as a corroborating “clinically relevant” assessment of disease severity, independently 
of assessments which are more specific to the disease under evaluation. 
The CGI can be completed in less than a minute, captures clinical impressions and can track 
clinical progress across time. It is administered by an experienced clinician who is familiar with 
the disease and the potential impact of treatment. The CGI rater can make an expert clinical 
global judgment about the severity of the illness across various time points within the context of 
that clinical experience [Busner and Targum, 2007]. The CGI has 2 established components, the 
CGI-S, which rates illness severity, and the CGI-C, which rates change from the initiation 
(baseline) of treatment. Both measures have been employed in the evaluation of investigational 
therapeutic agents for treatment of narcolepsy and both will be used within this proposed study. 
The CGI-S within this protocol will be used to rate the severity of the patient’s illness related to 
EDS symptoms, on a 7-point scale [Busner and Targum, 2007].These ratings are based on the 
clinician’s experience of patient’s suffering from the same condition [Berk et al, 2008]. This 
scale has classically been utilized in clinical research of a number of indications to observe and 
report average symptoms, behavior, and function over a 7-day period [Busner and Targum, 2007], 
in essence amalgamating the totality of a patient’s presentation into 1 score based upon 
physician’s judgments of clinical severity. Within this study, the CGI-S assessments will be 
based on severity related to EDS rather than on the totality of the disease [Szakacs et al, 2017; 
Dauvilliers et al, 2013]. 
7.2.2.2.2 Maintenance of Wakefulness Test 
The MWT is a common test used to measure latency to sleep onset/daytime 
somnolence/wakefulness [Doghramji et al, 1997; Black and Houghton, 2006]. 
 
 
 
 
 
 
 
 
 
 
 
 In general, 
the MWT has been extensively used for the clinical evaluation of sleep latency both in normal 
subjects as well as in patients with disease states such as narcolepsy, EDS, and obstructive sleep 
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7.2.2.3 
Exploratory Outcome Measures 
Given the need for hypothesis generation, exploratory measures have been included 
acknowledging that neither the patient phenotype, sample size, nor the duration of exposure may 
be adequate for definitive biostatistical contrasts. Exploratory measures include the evaluation of 
associated features of narcolepsy through a sleep diary (sleep attacks, severe sleepiness, 
cataplexy attacks, hypnagogic or hypnopompic hallucinations, sleep paralysis, nocturnal 
awakening, and nocturnal sleep time – all presented descriptively), changes in nocturnal 
overnight PSG, subjective assessments of EDS obtained through the ESS as an operationally 
defined responder analysis, CGI-C, and PGI-C.  
Additionally, exploratory analyses evaluate the impact of treatment on symptoms of EDS within 
each of the 4 MWT sessions within a single day (Day 7, Day 14). Specifically, the 
 
MWT will be performed after a nocturnal overnight PSG at baseline prior to the first dose of 
study medication, Day 7 (Visit 2), and Day 14 (Visit 3) according to validated standards. The 
first MWT session will occur at approximately 2 hours after awakening.  
There is no attempt to evaluate the occurrence of a discontinuation phenomenon at the end of double-
blind treatment given the duration of the study and the pharmacological properties of SUVN-G3031 
either through self-assessments, or clinician-based interview [Dauvilliers et al, 2013]. However, the 
occurrence of 2 AESIs during therapy, described as vivid and unpleasant dreams and difficulty 
initiating or maintaining sleep, will be monitored (see Section 12.7.2). 
7.2.2.3.1 Clinical Global Impression of Change 
The CGI-C will be used in this study to evaluate patient improvement related to EDS symptoms. 
The CGI-C is used by the physician to compare change in the patient’s clinical condition at each 
visit after initiation of treatment to an established baseline taken prior to study treatment. The 
CGI-C is based on a 7-point scale, where at each visit the physician will rate the change from 
baseline [Busner and Targum, 2007]. Within this study, the CGI-C assessment will be based on 
change observed from baseline related to EDS. 
7.2.2.3.2 Nocturnal Overnight Polysomnography 
Although PSG is not always required during the evening prior to an MWT assessment, it has 
been used to objectively demonstrate a lack of sleep disruption by residual effects of test product 
and is commonly used before MWT testing within the narcolepsy literature. For example, 
Harsh et al (2006) used PSG variables that included latency to persistent sleep in minutes (time 
from lights out to the first of 3 consecutive epoch of stage 1 sleep, or 1 epoch of any other sleep 
stage), number of arousals, number of awakenings, sleep efficiency, total sleep time in minutes, 
wake after sleep onset (WASO) in minutes, percentage of time in stage 1, 2, 3, 4, rapid eye 
movement (REM) sleep percentage, and REM sleep latency in minutes. Similarly, the US 


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Modafinil in Narcolepsy Multicenter Study Group PSG variables included total sleep time in 
minutes; sleep efficiency; percentage (sleep time/time in bed); percentage of time in stages 1, 2, 
3, 4; REM; sleep latency, minutes; REM latency, minutes; and periodically movements during 
sleep (N) [US Modafinil in Narcolepsy Multicenter Study Group, 2000]. 
7.2.2.3.3 Patient Global Impression 
The Patient Global Impression (PGI) is a self-assessed, single-item questionnaire typically with a 
7-point Likert-type scale a patient can select. There are 2 versions: a PGI-S to measure 
impression of disease severity at a single point in time, and a PGI-C to measure improvement or 
change based on a baseline state. For the proposed investigation, the PGI-C will be employed. 
The patient will be asked to address the totality of experience on study medication, without 
attempts to demarcate between excessive daytime somnolence and cataplexy. The PGI-C has 
categories regarding the condition being measured, from 1 (very much better) to 7 (very much 
worse).  
The PGI-C is a simple, direct, easy-to-use scale that is intuitively understandable to patients. The 
improvement scale aims to evaluate all aspects of patient’s health and determine if there has been 
an improvement or not compared with a point in time. Customarily, this is the pretreatment 
(baseline) condition of the patient prior to administration of study medication. Although it is 
generally used as a global assessment, the measure can be tailored to discrete symptoms within a 
clinical condition. The patient selects 1 response from the options that gives the most accurate 
description of his/her overall state of health. 
The test-retest reliability of the PGI-C was found to be excellent based on Cronbach’s alpha 
analysis of responses (0.849) at 6 months and 1 year in women undergoing surgery for urogenital 
prolapse [Srikrishna et al, 2010]. The PGI-C has been utilized as often as weekly in a number of 
indications [Ruoff et al, 2016]. 
The PGI has historical precedent for use in narcolepsy trials. A survey of 35 interventional 
studies in narcolepsy since 1994 suggests that approximately 3% employed a PGI rating of 
change as a primary or secondary outcome measure. For example, the PGI-C was a secondary 
endpoint in a Phase 2b study to evaluate the efficacy and safety of JZP-110 on wakefulness and 
sleepiness in adults with narcolepsy [Ruoff et al, 2016]. The PGI-C was administered at 1, 2, 4, 
6, 8, and 12 weeks, with the evaluation anchored to baseline condition. Significant benefits of 
JZP-110 relative to placebo were observed on the PGI-C as early as 1 week after treatment. 
7.2.2.3.4 Sleep Diary 
A sleep diary can be designed to document across a variety of associated signs or symptoms in 
narcolepsy: from time spent asleep to how many cataplectic attacks occur each day and how they 
manifest themselves. Subjects are generally instructed to try to keep track of the day’s events 
with notes and to fill out the diary regularly, at minimum once daily, and data can be captured 
electronically or on paper.  


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There is no single standard for the structure of a sleep diary. Review of existing literature 
indicates considerable heterogeneity in the signs/symptoms associated with narcolepsy which 
have been assessed, consistent with hypotheses and patient populations evaluated. The sleep 
diary used by the Harvard Medical School – Division of Sleep Medicine will be used in this 
study. Further details can be found in Section 11.7. 
A 2017 study analyzed how many nights of sleep diary entries were required for reliable 
estimates of 5 sleep-related outcomes (bedtime, wake time, SOL, sleep duration, and WASO) in 
adolescents. Participants completed a pencil and paper sleep diary across 1 week during the 
school term. Variables included bedtime (“Went to bed last night at”), SOL (“Minutes until fell 
asleep”), sleep duration (“Slept this much last night”), WASO (“After you fell asleep, what is the 
total amount of time you spent awake during any nighttime awakenings?”), and wake time 
(“Finally woke at”). For each item, adolescents were instructed to answer with a specific time 
(e.g., 9:35 pm) or duration (e.g., 12 minutes). Participants also concurrently wore wrist 
actigraphs (Mini-motionlogger; Ambulatory Monitoring Inc. [Ardsley, NY]) and called a 
time-stamped answering machine before bedtime and after they woke each day 
[Short et al, 2017]. 
A 2010 paper discussed the development of an online sleep diary. It included bedtime, time the 
subject went to bed, time they settled for sleep, and an estimate of how long it took them to go to 
sleep. It also included wake time, time to get out of bed, number of awakenings during the night, 
and estimated time awake. It also included checkboxes for reasons the subject awoke, and 
whether anything kept them awake. Finally, it evaluated sleep quality by asking subjects how 
they felt on a 4-point scale and their mood on a 4-point scale [Blake and Kerr, 2010]. 
A 2012 study compared sleep diaries from an expert panel of 25 attendees of a Pittsburgh 
Assessment Conference. A smaller subset of experts formed a committee and reviewed the 
compiled diaries. Items deemed essential were included in a core sleep diary, and those deemed 
optional were retained for an expanded diary. Essential elements of the sleep diary included 
metrics to assess nightly SOL, WASO, total sleep time, total time spent in bed, sleep efficiency 
(i.e., the percent of the time asleep out of amount of time spent in bed), and sleep quality or 
satisfaction, which reflects a subjective global appraisal of each night’s sleep. 
Three versions of sleep diaries were created. The core Consensus Sleep Diary (CSD) contained 
9 items considered by the workgroup to represent the most critical parameters. The questions ask 
about: (1) the time of getting into bed; (2) the time at which the individual attempted to fall 
asleep; (3) SOL; (4) number of awakenings; (5) duration of awakenings; (6) time of final 
awakening; (7) final rise time; (8) perceived sleep quality (rated via Likert scale); and (9) an 
additional space for open-ended comments from the respondent. As previously agreed upon, the 
core CSD was formatted so that 1 week of nightly sleep data could be recorded on a single diary 
page. The CSD instructions included general information, such as what to do if the respondent 
missed recording on a particular day, and item-specific instructions to enhance likelihood of 
correct item interpretation. For example, the instructions for item #6 tell the respondent to record 


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the time of the final awakening in the morning. The additional instructions indicate that all items 
are to be completed in the morning within 1 hour of getting out of bed. 
The expanded CSD for morning included a number of optional items that could be completed in 
the morning upon arising. These include additional items about early (premature) morning 
awakenings, estimated total sleep time, Likert scale rating of the refreshing quality of sleep, 
napping/dozing, and alcohol, caffeine, and medication use. The instructions for the additional 
questions also stipulate that the diary should be completed in the morning. 
Finally, the expanded CSD for evening included the same items as the morning version, but with 
instructions for morning and evening completion. The morning and evening items are grouped 
separately. The instructions stipulated that items about daytime activity such as caffeine, alcohol, 
and medication use or napping which appeared on 1 side of the diary are to be completed at night 
before going to bed, while the remaining items which appeared on the other side and query about 
the previous night's sleep are to be completed the next morning [Carney et al, 2012]. 
Sleep diaries have been used extensively in narcolepsy trials. A survey of 35 interventional 
studies in narcolepsy since 1994 suggests that approximately 46% employed a sleep diary as a 
primary or secondary outcome measure. For example, a 4-week, double-blind, randomized, 
placebo-controlled trial evaluated time to response with sodium oxybate for the treatment of 
EDS and cataplexy in patients with narcolepsy. There were 102 patients who received sodium 
oxybate and 34 who received placebo. Clinical response information included the number of 
cataplexy attacks recorded by patients in a daily diary. Cataplexy responder was defined as a 
patient with≥ 50% reduction from baseline in weekly cataplexy attacks. Results showed an 
approximately 50% reduction from baseline in weekly cataplexy attacks was the median change 
after 2 weeks of treatment with sodium oxybate [Bogan et al, 2015]. 
The sleep diary from Harvard Medical School – Division of Sleep Medicine will be used in this 
study to evaluate nightly sleep parameters throughout the duration of the study as indicated in the 
Schedule of Assessments (Table 1).  
Sleep diaries will be distributed to eligible patients during the screening window and patients 
will start to record their sleep evaluations in it immediately. Diary entries will be reviewed at 
baseline and all subsequent visits. 
7.2.2.3.5 Columbia Suicide Severity Scale 
The CSSRS is a rating scale addressing suicide ideation and behavior. Questions assess ideation 
from a “wish to be dead” to “active suicidal ideation with specific plan and intent and 
behaviors”. Questions assessing behavior rate it from “actual attempt” to “completed suicide”. 
The trial will employ 2 distinct CSSRS forms: The Baseline-Screening version assesses lifetime 
prevalence of suicidal ideation and suicidal behavior, and the Since Last Visit form assesses 
ideation and behavior that have emerged since the last study visit. 
The CSSRS has been shown to demonstrate good convergent and divergent validity with other 
multi-informant suicidal ideation and behavior scales and had high sensitivity and specificity for 


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suicidal behavior classifications compared with other behavior scales and an independent suicide 
evaluation board. Both the ideation and behavior subscales have been shown to be sensitive to 
change over time [Posner et al, 2011]. 
7.3 
End of Study 
A patient will have fulfilled the requirements for study completion when the patient has 
completed all study visits including the Day 21 safety follow-up visit. 
The end of study is defined as the last patient’s last visit. 


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8 
SELECTION OF STUDY POPULATION 
Section 7.1 provides information regarding the number of patients planned to be randomized. 
8.1 
Inclusion Criteria 
Individuals must meet all of the following criteria to be included in the study: 
1. Must be between the ages of 18 to 65 years, inclusive. 
2. Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International 
Classification of Sleep Disorders (3rd Edition) criteria for the diagnosis of narcolepsy (new or 
previously diagnosed). 
3. Have undergone an MSLT study showing an MSLT of ≤ 8 minutes with 2 or more 
SOREMPs performed according to standard techniques, with substitution of 1 of the required 
SOREMPs on MSLT with 1 obtained from the preceding nocturnal PSG, performed at the 
time of diagnosis. No other potential cause for EDS must have been identified during the 
preceding nocturnal PSG. If the study site is unable to obtain the MSLT diagnoses, the 
MSLT may be performed to confirm diagnoses upon Sponsor and medical monitor approval. 
4. An ESS score of ≥ 12; and mean MWT time of < 12 minutes across the first 4 sessions at 
baseline. An ESS score of ≥ 12 for eligibility is only required at the Baseline visit. An ESS 
score of < 12 at Screening due to concomitant medications will be subjected to PI’s 
discretion for eligibility.  
5. Must have a body mass index ranging from 18 to < 45 kg/m2. 
6. Negative urine drug screen (UDS) at the Screening and Baseline (Visit 1) visits.  
• 
A positive UDS at Screening can be repeated up to Day -1; however, a negative UDS is 
required prior to Day 0 (Baseline visit), and a second negative UDS is required on Day 0 
(Baseline visit). 
• 
A positive UDS at Screening due to concomitant medications will be subject to PI’s 
discretion for eligibility. 
7. All patients must agree to remain free of alcohol and illicit drugs from Screening and until 
the Safety Follow-up visit. 
8. All male patients who are sexually active and not surgically sterilized must agree to use a 
condom with or without spermicide, in addition to any birth control used by their partner 
during the study until 1 month after the final dose of investigational product (IP).  
9. Before randomization, a woman must be either not of childbearing potential or of 
childbearing potential practicing highly effective methods of birth control. 
• 
“Not of childbearing potential” is defined as a patient who is postmenopausal (> 45 years 
of age with amenorrhea for at least 12 months); permanently sterilized (e.g., tubal 
occlusion, hysterectomy, bilateral salpingectomy); or otherwise is incapable of pregnancy 


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(due to reasons including bilateral blocked fallopian tubes, bilateral oophorectomy, 
androgen insensitivity syndrome, and Müllerian agenesis). 
• 
“Of childbearing potential” and practicing a highly effective method of birth control is 
defined as a patient following regulations consistent with the use of birth control methods 
for patients participating in clinical studies. A highly effective method of birth control is 
a method with low user dependency that results in a low failure rate (i.e., less than 1% per 
year) when used consistently and correctly. Nonexhaustive examples of highly effective 
methods include: e.g., established use of oral, injected, or implanted hormonal methods 
of contraception; placement of an intrauterine device or intrauterine system; barrier 
methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap 
(diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; 
male partner sterilization (the vasectomized partner should be the sole partner for that 
patient), or male partner is using condoms with spermicide; practicing true abstinence 
(the preferred and usual lifestyle of the patient). Two forms of effective methods of birth 
control must be used during the study and for 1 month after the last dose of IP. 
10. Willingness to complete the study protocol with full compliance with procedures and sign an 
informed consent form (ICF). 
8.2 
Exclusion Criteria 
Individuals meeting any of the following criteria at Screening or baseline are ineligible to 
participate in this study: 
1. Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of 
< 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries. 
2. Use of any investigational therapy within the 30-day period prior to enrollment. 
3. Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline 
assessments and during the course of the trial. (See Appendix 3 for caffeine dosage 
definitions). 
4. Nicotine dependence that has an effect on sleep (e.g., a patient who routinely awakens at 
night to smoke). 
5. Use of concurrent medications prescribed to treat narcolepsy or any indication as specified 
including stimulants, antidepressants and sodium oxybate before Baseline and until the 
Safety Follow-up visit, as specified in Appendix 2. 
6. Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any 
other cause of daytime sleepiness. If the Investigator confirms that any of the following 
syndromes are not clinically significant to the extent that it is causing sleep disturbance, this 
patient may be permitted at the Investigator’s discretion): 


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• Obstructive sleep apnea, or individuals requiring continuous positive airway pressure 
(obstructive sleep apnea noted during nocturnal PSG should be queried). 
• Periodic limb movement disorder (periodic limb movements noted during nocturnal PSG 
should be queried).  
• Other clinically significant disorders which cause sleep disruption (e.g., chronic pain 
disorder, chronic or untreated insomnia, clinically significant levels of gastroesophageal 
reflux disease, asthma, neuropathy, or other chronic pain disorders such as osteoarthritis 
or degenerative joint disease). 
• Hypothyroidism requires Investigator assessment to determine whether it contributes to 
interrupted or poor sleep, (i.e., causing daytime somnolence). 
• Parasomnias. 
• Significant nocturia. 
7. Clinically significant ECG abnormalities. Patients are excluded with a screening ECG PR 
interval of ≥ 300 msec, QRS interval ≥ 200 msec, or Fridericia’s correction of QT interval 
≥ 450 msec for men and ≥ 470 msec for women obtained after 3-minute rest in a supine 
position using a digital ECG. Abnormal results for ECGs should be repeated once at 
screening with 3 consecutive ECG recordings to ensure reproducibility of the abnormality 
before excluding a subject based on the exclusion criteria. Each ECG recording should be 
taken approximately 5 minutes apart (the ECG result reported would be evaluated at each 
time point). A subject will be excluded if the QTcF is ≥ 450 msec in men and ≥ 470 msec in 
women for 2 of the 3 time points of the ECGs done, unless due to ventricular pacing. If only 
1 ECG time point has a QTcF of ≥ 450 msec in men and ≥ 470 msec in women, and this is 
not reproduced at either of the other 2 time points, the subject can be included in the trial. 
8. Concurrent use of sedating agents such as hypnotics, tranquilizers, sedating antihistamines, 
antipsychotics, benzodiazepines, anticonvulsants, clonidine or tricyclic antidepressants which 
have H1-antihistamine properties (clomipramine, protriptyline) before Baseline and until the 
Safety Follow-up visit, as specified in Appendix 2. 
9. History of (within past 3 months) or current substance use disorder involving illicit drugs, 
alcohol, or marijuana, as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) 
criteria and non-disordered use of alcohol and recreational drugs. 
10. History or presence of any unstable medical condition or neurological disorder which may 
affect the patient’s safety or stability (such as serious cardiovascular disorder, moderate or 
severe gastrointestinal abnormalities, hepatic disorder or renal abnormalities, hepatitis C, 
hepatitis B, human immunodeficiency virus positive status, history of epilepsy, significant 
head injury, history of intracranial surgery, or malignancy in past 5 years). 


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11. Patients with preplanned surgeries requiring general anesthesia throughout the duration of the 
trial. 
12. Severe, unstable psychiatric illness including a diagnosis of bipolar disorder, schizophrenia 
or psychotic disorder in the patient’s lifetime, according to DSM-5 criteria. Patients with 
severe or uncontrolled depression that, in the judgment of the Investigator, makes the patient 
inappropriate for entry into the study or which will require new onset of treatment during the 
course of the trial. Subjects who are at significant potential suicidal risk are determined by: 
• Patients who answer “Yes” on the CSSRS Suicidal Ideation Item 4 (active suicidal 
ideation with some intent to act, without specific plan) and whose most recent episode 
meeting criteria for this CSSRS Item 4 occurred within the last 6 months; or 
• Patients who answer “Yes” on the CSSRS Suicidal Ideation Item 5 (active suicidal 
ideation with specific plan and intent) and whose most recent episode meeting criteria for 
this CSSRS Item 5 occurred within the last 6 months; or 
• Patients who answer “Yes” on any of the 5 CSSRS Suicidal Behavior Items (actual 
attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose 
most recent episode meeting criteria for any of these 5 CSSRS Suicidal Behavior Items 
occurred within the last 2 years; or 
• Patients who, in the opinion of the Investigator, present a serious risk of suicide. 
13. An occupation requiring variable shift work, night shifts, or frequent overnight travel which 
disrupts sleep patterns. 
14. In the opinion of the Investigator, it would be unsafe for a patient to stop taking any wake 
promoting agent for more than 4 weeks. The patient’s occupation (e.g., requirement for 
driving) may need to be considered. 
8.3 
Rescreening 
Individuals who sign the ICF to participate in the study but who do not subsequently meet all the 
requirements as outlined in the inclusion and exclusion criteria and therefore do not enroll 
(screen failures) may be rescreened on a case-by-case basis after approval of the Sponsor. 
8.4 
Study Withdrawal, Removal, and Replacement of Patients 
If a patient discontinues study treatment and is withdrawn from the study for any reason, the 
study site must immediately notify the medical monitor. The date and the reason for study 
discontinuation must be recorded on the electronic case report form (eCRF). Patients who 
complete or discontinue early from the study will be asked to return to the study site within 
7 days of the last administration of study drug to complete the safety follow-up assessments as 
indicated in the Schedule of Assessments (Table 1). 
Patients who want to discontinue early from the study (i.e., at the next visit), or who make a 
decision to withdraw during a scheduled visit, and who remain on study drug should complete 


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the rating scale/assessments indicated for that visit (Visit 2 or Visit 3) as well as the safety 
follow-up assessments according to the Schedule of Assessments (Table 1). 
In the event that a patient discontinues prematurely from the study because of a TEAE or serious 
TEAE, the TEAE or serious TEAE will be followed until it resolves (returns to normal or 
baseline values) or stabilizes, or until it is judged by the Investigator to no longer be clinically 
significant. 
Once a patient is withdrawn from the study, the patient may not re-enter the study. Care of the 
patient will return to their usual doctor. 
A patient may voluntarily withdraw or be withdrawn from the study at any time for reasons 
including, but not limited to, the following: 
• Unacceptable toxicity or AE. 
• Clinically significant abnormal lab values: 
o Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 8x upper 
limit of normal (ULN);  
o ALT or AST ≥ 3x ULN and total bilirubin ≥ 2x ULN at the same visit;  
o ALT or AST ≥ 3x ULN with the appearance of symptoms indicating hepatitis (e.g., 
worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, 
rash, or eosinophilia).  
• QT syndrome, Fridericia’s formula corrected QT (QTcF) interval ≥ 470 ms (for male 
subjects) or ≥ 480 ms (for female subjects), or torsades de pointes. Abnormal results for 
ECGs should be confirmed with repeat ECG recordings to ensure reproducibility of the 
abnormality before withdrawing the subject from the study. 
• A positive urinary drug screen at any visit. 
• Patient withdrawal of consent: at any time, a patient’s participation in the study may be 
terminated at his/her request or on the basis of the Investigator’s clinical judgment. The 
reason for patient withdrawal will be noted on the eCRF. 
• Intercurrent illness: a condition, injury, or disease unrelated to the primary diagnosis that 
became apparent during treatment and necessitated the patient’s termination from the 
study. 
• General or specific changes in the patient’s condition that renders him/her ineligible for 
further treatment according to the inclusion/exclusion criteria. 
• Patient fails to adhere to the protocol requirements (e.g., drug noncompliance, failure to 
return for defined number of visits). 
• Lost to follow-up: the patient stopped coming for visits, and study personnel were unable 
to contact the patient. 


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• Pregnancy, as indicated in Section 12.7.6. 
Additionally, the Sponsor may stop the study at any time for safety, regulatory, legal, or other 
reasons aligned with Good Clinical Practice (GCP). This study may be terminated at the 
discretion of the Sponsor or any regulatory agency. An Investigator may elect to discontinue or 
stop the study at his or her study site for any reason, including safety or low enrollment. 


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9 
TREATMENTS 
9.1 
Details of Study Treatments 
The study treatments to be used in this study are: 
• 2 mg SUVN-G3031 
• 4 mg SUVN-G3031 
• Placebo 
All study treatment supplies to be used in this study will be provided by the Sponsor. 
Study treatment is provided in high density polyethylene (HDPE) bottles containing 10 tablets. 
Each bottle will contain the patient identification number, the name and address of the Sponsor, 
and any other information required by local regulations. Study treatment supplies should be 
stored in accordance with United States Pharmacopeia (USP) Controlled Room Temperature 
(20–25°C [68–77°F] with excursions permitted between 15 and 30°C [59–86°F]). Further 
information is provided in the Pharmacy Manual. 
9.2 
Dosage Schedule 
Patients should take 1 tablet per day in the morning, as soon as they wake up, with 
approximately 250 mL water. Dosing may occur with or without food. Patients will be dosed for 
14 days. 
If a patient forgets to take their morning dose and remembers before 1:00 PM, then they should 
take it as soon as they remember. If a patient forgets to take their morning dose and remembers 
after 1:00 PM, then they should skip the day’s dose and take the next scheduled dose the next 
morning. If the patient has missed more than 1 dose, then they should only take the most recent 
forgotten dose. 
9.3 
Measures to Minimize Bias: Study Treatment Assignment and Blinding 
9.3.1 
Method of Study Treatment Assignment 
Patients will be randomized to the 3 study treatments in a 1:1:1 ratio. This randomization will be 
stratified by at least 30% each based on whether they have narcolepsy with or without cataplexy 
(Na-1 or Na-2), respectively. 
Patients will be randomized using an interactive response technology (IRT). The randomization 
number generated should be entered into the eCRF. Further details will be provided in the 
Pharmacy Manual. 
9.3.2 
Blinding 
This is a double-blind study. Tablets will be provided, pre-dispensed in blinded study kits. All 
tablets will be identical in appearance and size. 
According to the randomization schedule as indicated in the Schedule of Assessments (Table 1) 
and in accordance with the Pharmacy Manual, the Investigator or designee will obtain the kit 


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number from the IRT for the patient and the kit number will be provided to the blinded 
pharmacist or designee at the study center who is responsible for the preparation of study drug. 
The blinded pharmacist will then dispense the correct kit number to the patient. 
Each patient will receive 2 kits: the first for Days 1 to 7 and the second for Days 8 to 14. The kits 
numbers should be recorded in the eCRF and in the pharmacy dispensing logs. 
If an Investigator becomes unblinded to a given patient’s study treatment that patient will be 
discontinued from the study unless there are ethical reasons for that patient not to be 
discontinued; approval from the Sponsor’s medical monitor must be obtained in such instances. 
In the event that emergency unblinding is required for a given patient because of AEs or 
concerns for the patient’s safety or wellbeing, the Investigator may break the randomization code 
for the patient via the IRT, by which system the unblinding will be captured. The Investigator is 
responsible for notifying the medical monitor and/or Sponsor of such an event as soon as 
possible. The unblinding and its cause will also be documented in the eCRF. 
9.4 
Dosage Modification 
No dose modification is permitted during this study. 
9.5 
Treatment Accountability and Compliance 
The pharmacist or other designated individual will maintain records of study treatment delivered 
to the study site, the inventory at the study site, the distribution to and use by each patient and the 
return of any required materials to the Sponsor. Study sites will be responsible for disposal of 
study treatment. Records should include dates, quantities, batch/serial numbers, expiration dates, 
in-clinic temperature log, and unique code numbers assigned to the product and study patients. 
At each visit after initiation of treatment, study site personnel will record compliance of the 
patient with the patient’s assigned regimen. Patients will be instructed to bring their diaries and 
unused/partially used/empty bottles back for inspection at each study visit. Patients are to be 
reminded of the importance of compliance with their assigned regimen, with an emphasis on 
taking their study drug on schedule and maintaining the prescribed interval between doses. 
Investigators will maintain records that adequately document that the patients were provided 
with the correct study treatment kits and reconcile the products received from the drug 
dispensing center. Investigational product will not be disposed until accountability has been fully 
monitored. 
Medication containers must be returned at each visit, as compliance will be assessed by tablet 
counts. Noncompliance is defined as taking less than < 80% or more than 120% of study drug 
during any outpatient evaluation period (visit to visit). Discontinuation for noncompliance is at 
the Investigator’s discretion and is to be noted on the eCRF. 


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9.6 
Prior and Concomitant Therapy 
9.6.1 
Prior and Concomitant Medications 
Restricted prior therapies are provided in Appendix 2. All medications and other treatments 
taken by the patient during the study, including those treatments initiated before the start of the 
study, must be recorded on the eCRF. 
Medications taken by or administered to the patient for the time period before Screening will be 
recorded in the eCRF. After the baseline visit, medication to treat minor treatment-emergent 
illness(es) is generally permitted; however, the following therapies are expressly prohibited 
throughout the study:  
• Adjunctive pharmacotherapy directed against EDS (including but not limited to 
methylphenidate, dextroamphetamine, methamphetamine, modafinil, and armodafinil)  
• Adjunctive pharmacotherapy directed against cataplexy (including but not limited to 
venlafaxine, fluoxetine, and gamma hydroxybutyrate) 
• Clomipramine 
• Protriptyline 
• Pitolisant 
Any medication or therapy that is taken by or administered to the patient during the course of the 
study must be recorded in the eCRF. The entry must include the name, dose, regimen, route, 
indication, and dates of use. 
After written informed consent is obtained from the patient, those patients who are taking the 
following medications must have the minimum washout periods specified below and not take 
the medications for the duration of the study: 
• 14 days before randomization for agents targeting cataplexy  
• 7 days before randomization for agents targeting EDS 


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10 STUDY PROCEDURES 
Table 1 outlines the timing of procedures and assessments to be performed throughout the study. 
Section 12.5 specifies laboratory assessment samples to be obtained. See Sections 11, 12, and 13 
for additional details regarding efficacy assessments, safety assessments and PK sampling, 
respectively. 
 


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Table 1. 
Schedule of Assessments 
Visit 
Screening 
Visit 1 
Visit 2 
Visit 3 
Safety Follow-up 
Study Day 
Day -28 to Day -1 
Baseline (Day 0) 
Day 7 
Day 14 
Day 21 
Window 
 
 
±1 day 
±1 day 
±1 day 
Informed consent 
X 
 
 
 
 
Demographic information 
X 
 
 
 
 
Medical History and Disease History 
X 
 
 
 
 
Virology/Serologya 
X 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
Physical examination 
X 
X 
 
X 
X 
Vital signsb 
X 
X 
X 
X 
X 
ECG 
X 
Xc 
Xc 
Xc 
X 
Hematologyd 
X 
X 
 
X 
X 
Serum chemistryd 
X 
X 
 
X 
X 
Pharmacokinetic samplee 
 
X 
X 
X 
 
Urinalysisd 
X 
X 
 
X 
X 
Pregnancy testf 
X 
X 
X 
X 
X 
UDSg 
X 
X 
X 
X 
 
Nocturnal overnight PSGh 
 
X 
X 
X 
 
MWTi 
 
X 
X 
X 
 
CGI-Sj 
 
X 
X 
X 
 
CGI-Cj 
 
 
X 
X 
 
ESSk 
X 
X 
X 
X 
 
CSSRSk 
X 
X 
X 
X 
X 
PGI-Ck,l 
 
X 
X 
X 
 
Diary dispensingm 
X 
X 
X 
X 
 
Washout from EDS/cataplexy medicationsn 
X 
 
 
 
 
Assign/randomize to IP 
 
X 
 
 
 




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k ESS, PGI-C, CSSRS assessments will be completed in this order at the beginning of each evaluation day prior to start of first MWT session. Note: 2 distinct 
forms of CSSRS will be used: “Baseline-Screening” form will be used at Screening and “Since Last Visit” form will be used at subsequent visits. 
l For the PGI-C, the patient will be asked to address the totality of experience on study medication, without attempts to demarcate between excessive daytime 
somnolence versus cataplexy. 
m Sleep diary is collected nightly by the patient from Screening through Visit 3. The patient will provide the sleep diary from the preceding week at the 
beginning of each visit. In addition, dosing data will be collected in the diary. 
n Washout period will occur within a maximum 28-day Screening period to allow for minimum drug free period of ≥ 7 days for all stimulants targeting EDS, 
and ≥ 14 days for all agents targeting cataplexy prior to randomization and baseline (Day 0) assessments. 
o At the start of each visit as indicated, the patient will return IP that has not been used, provide sleep diary, report any modification in concomitant medication 
dosage or regimen, and research personnel will complete a nondirected inquiry for the detection of AEs. Safety assessments completed by the Investigator 
precede the efficacy assessments. 
p Concomitant medications and AEs may be collected prior to the PSG and the first MWT. 
 


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10.1 Informed Consent 
Before performing any study-related procedures, the Investigator (or designee) will obtain 
written informed consent from the patient. 
10.2 Study Procedures 
Assessments and their timing are to be performed as outlined in the Schedule of Assessments 
(Table 1). Section 12.5 specifies laboratory assessment samples to be obtained.  
Efficacy assessments are described in Section 11 and include MWT, CGI-S, ESS, CGI-C, 
PGI-C, nocturnal overnight PSG, and sleep diary. 
Safety assessments are described in Section 12 and include vital signs, physical examinations, 
ECGs, laboratory assessments, CSSRS, AEs, and AESIs. 
The PK assessments are described in Section 13. 
The Investigator may, at his/her discretion, arrange for a patient to have an unscheduled 
assessment, especially in the case of AEs that require follow-up or are considered by the 
Investigator to be possibly related to the use of study drug. The unscheduled visit page in the 
eCRF must be completed. 
Study discontinuation procedures are described in Section 8.4. Follow-up of AEs and SAEs 
leading to study discontinuation are described in Section 8.4. 
10.2.1 
Assessment Order 
During Visits 1 to 3, assessments should be performed in the following order, as applicable (not 
all procedures are required at all visits): 
• Admit the night before the visit 
• Inclusion/exclusion criteria (Visit 1 only) 
• Collect IP (Visits 2 and 3 only) 
• Concomitant medication check 
• Adverse event check 
• Urine collection for urine drugs screen (Visits 1, 2, and 3) and pregnancy test (Visits 1, 2, 
3, and Safety Follow-up visits) 
• Serum pregnancy test (Visit 1 only) 
• Nocturnal overnight PSG 
• Physical examination (Visits 1 and 3 only) 
• Urine collection for urinalysis (Visits 1 and 3 only) 
• Baseline ECG (Visit 1 only) 


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• Vital signs 
• CGI-S 
• CGI-C (Visits 2 and 3 only) 
• Blood collection for safety (Visits 1 and 3 only) and PK (Visits 1, 2, and 3) 
• Dosing (as soon as the patient wakes up; Visits 2 and 3 only) 
• ESS 
• PGI-C 
• CSSRS 
• MWT 1 (approximately 2 hours after awakening) 
• Postdose ECG (approximately 3 hours postdose; Visits 2 and 3 only) 
• PK (approximately 3 hours postdose; Visits 2 and 3 only) 
• MWT 2 (2 hours post MWT 1) 
• MWT 3 (2 hours post MWT 2) 
• MWT 4 (2 hours post MWT 3) 
• Randomization (Visit 1 only) 
• Dispense IP (Visits 1 and 2 only) 
• Dispense diary 
• Discharge 


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11 EFFICACY ASSESSMENTS 
The Schedule of Assessments (Table 1) outlines the efficacy assessments to be performed 
throughout the study and their timing. 
11.1 Maintenance of Wakefulness Test 
The 
MWT will be utilized within this study and will be performed following a 
nocturnal overnight PSG at the times outlined in the Schedule of Assessments (Table 1). The 
MWT will begin at approximately 2 hours after awakening (4 total MWT sessions will be 
performed at 2-hour intervals). Patients will be required to recline in a quiet, dimly lit bedroom 
and instructed to remain awake for as long as possible. The MWT trial will be stopped after the 
onset of sleep or after 
 if sleep did not occur. The onset of sleep will be evaluated 
using a standard PSG montage and defined as 3 consecutive 30-second epochs of stage 1 sleep or 
30 seconds of sleep stage 2, 3, 4, or REM sleep. 
11.2 Clinical Global Impression of Severity 
The CGI-S will be used to rate the severity of the patient’s illness related to EDS symptoms, on a 
7-point scale, which includes the following gradations: 1 = normal, not at all ill; 2 = borderline 
ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most 
extremely ill. These ratings should be based on the clinician’s experience of patients suffering 
from the same condition. The ratings should be completed by the same physician for each patient 
throughout the study in order to maintain consistency. 
11.3 Epworth Sleepiness Scale 
The ESS consists of 8 questions in which the patient will be asked “How likely are you to doze 
off or fall asleep in the following situations, in contrast to feeling just tired?” 
• Sitting and reading  
• Watching television 
• Sitting, inactive in a public place (e.g., a theatre or a meeting) 
• As a passenger in a car for an hour without a break 
• Lying down to rest in the afternoon when circumstances permit 
• Sitting and talking to someone 
• Sitting quietly after a lunch without alcohol 
• In a car, while stopped for a few minutes in traffic 
Patients will be asked to respond to each question with a score of 0–3 where: 
• 0 = would never doze 
• 1 = slight chance of dozing 


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• 2 = moderate chance of dozing  
• 3 = high chance of dozing 
The ESS will be completed by the patients themselves. 
11.4 Clinical Global Impression of Change 
The CGI-C is used by the physician to compare change in the patient’s clinical condition at each 
visit after initiation of treatment to an established baseline taken prior to study treatment.  
The CGI-C is based on a 7-point scale, where at each time point the physician will rate the 
change from baseline using the following query: “Compared to the patient's condition at 
admission to the project [prior to medication initiation], this patient's condition is: 1 = very much 
improved since the initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no 
change from baseline (the initiation of treatment); 5 = minimally worse; 6 = much worse; 
7 = very much worse since the initiation of treatment.” Within this study, the CGI-C assessment 
will be based on change observed from baseline related to EDS rather than on the totality of the 
disease. 
The ratings should be completed by the same physician for each patient throughout the study in 
order to maintain consistency. 
11.5 Patient Global Impression of Change 
The PGI-C is used by the patient to compare change in their clinical condition at each visit after 
initiation of treatment to an established baseline taken prior to study treatment.  
The PGI-C is based on a 7-point scale, where at each time point the patient will rate the change 
from baseline using the following query: “Since the start of the study, my overall status is: 
1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 
6 = much worse; 7 = very much worse.” Within this study, the PGI-C assessment will be based 
on change observed from baseline related to EDS rather than on the totality of the disease. 
The patient will be asked to address the totality of experience on study medication, without 
attempts to demarcate between excessive daytime somnolence and cataplexy. 
11.6 Nocturnal Overnight Polysomnography 
The nocturnal overnight PSG will be completed at the times outlined in the Schedule of 
Assessments (Table 1). Variables to be collected will include latency to persistent sleep in 
minutes (latency from lights-off to the first epoch of 20 consecutive epochs of any stage of 
sleep), number of arousals, number of awakenings, sleep efficiency, total sleep time in minutes, 
WASO in minutes, percentage of time in stage 1, 2, 3, 4, REM sleep percentage, REM sleep 
latency in minutes and periodically movements during sleep (N).  


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11.7 Sleep Diary 
The sleep diary uses the following headers in a table that patients should complete daily, in 
relation to the onset, duration, and quality of sleep: 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The diary will be completed electronically using a handheld eDiary. 


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12 SAFETY ASSESSMENTS 
Safety assessments (vital signs, physical examinations, ECG recording, AEs, AESIs, CSSRS, 
and clinical laboratory results [routine hematology and biochemistry]) are to be performed at 
protocol-specified visits, as specified in the Schedule of Assessments (Table 1). 
12.1 Medical History and Disease History 
Medical history will be recorded at Screening. Investigators should document the occurrence, 
signs, and symptoms of the patient’s pre-existing conditions, including all prior significant 
illnesses. Additional pre-existing conditions present at the time when informed consent is given 
and up to the time of first dosing are to be regarded as concomitant. Medical history will include 
alcohol consumption, smoking, substance abuse, and psychiatric history. 
A detailed medical history will be taken in relation to the patient’s narcolepsy (including 
cataplexy, if applicable). This will include date of diagnosis, diagnostic tests undertaken and 
symptoms experienced. 
Illnesses first occurring or detected during the study and/or worsening of a concomitant illness 
during the study are to be documented as AEs on the eCRF in accordance with Section 12.7. All 
changes not present at baseline or described in the past medical history and identified as 
clinically noteworthy must be recorded as AEs. 
Additionally, demographic data will be collected for all patients and will include date of birth, 
sex, and ethnicity. 
12.2 Vital Signs 
Vital signs (body temperature, respiration rate, heart rate, and systolic and diastolic blood 
pressure measurements) will be evaluated at the visits indicated in the Schedule of Assessments 
(Table 1). All vital signs will be measured after the patient has been resting in a sitting position 
for at least 5 minutes. Blood pressure measurements are to be taken in the same arm for the 
duration of the study. Body weight (without shoes) will be recorded whenever vital signs are 
recorded; height (without shoes) will be recorded at Screening only. 
Vital sign measurements will be repeated if clinically significant or machine/equipment errors 
occur. Out-of-range blood pressure, respiratory rate, or heart rate measurements will be repeated 
at the Investigator’s discretion. Any confirmed, clinically significant vital sign measurements 
must be recorded as AEs. 
12.3 Physical Examination 
A complete physical examination (head, eyes, ears, nose and throat; heart; lungs; abdomen; skin; 
cervical and axillary lymph nodes; and neurological and musculoskeletal systems) will be 
performed at the visits indicated in the Schedule of Assessments (Table 1). Physical 
examinations will be performed by a physician or licensed practitioner. 


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12.4 Electrocardiograms 
A 12-lead, resting ECG will be obtained at the visits indicated in the Schedule of Assessments 
(Table 1). The following parameters will be measured at a minimum: heart rate, PR, QRS, QT 
and Fridericia's correction of QT intervals. The same ECG machines should be used for each 
patient throughout the study. 
At Screening, the Investigator will examine the ECG traces for signs of cardiac disease that 
could exclude the patient from the study. An assessment of normal or abnormal will be recorded; 
if the ECG is considered abnormal, the abnormality will be documented on the eCRF. 
Electrocardiograms will be repeated if clinically significant abnormalities are observed or 
artifacts are present. A central cardiac laboratory will be used in this study. 
12.5 Laboratory Assessments 
Laboratory assessment samples (Table 2) are to be obtained at designated visits as detailed in the 
Schedule of Assessments (Table 1). 


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Table 2. 
Laboratory Assessments 
Hematology 
Serum Chemistry 
Urine Analysis (Dipstick) 
Hematocrit 
Hemoglobin 
Red blood cell count 
White blood cell count with 
differential 
Platelets 
Red blood cell indices 
Albumin 
Alanine aminotransferase 
Alkaline phosphatase 
Aspartate aminotransferase 
Blood urea nitrogen or urea 
Creatinine 
Electrolytes (sodium, potassium, 
chloride, calcium) 
Gamma glutamyltransferase 
Glucose 
Lactate dehydrogenase 
Total bilirubin 
Direct bilirubin 
Uric acid 
Follicle-stimulating hormonea 
Thyroid stimulating hormoneb 
Appearance 
pH 
Protein 
Glucose 
Ketone bodies 
Indicators of blood and white blood 
cells 
Specific gravity 
Urobilinogen 
Microscopic analysis will occur 
when dipstick indicates clinically 
significant changes in one of the 
above. 
Virology/Serology tests: Virology and Serology laboratory tests (i.e., Hepatitis B, Hepatitis C, and human 
immunodeficiency virus) will be completed at Screening. 
Pregnancy test: A urine pregnancy test will be performed on all women of childbearing potential at Screening, 
baseline, Day 7, Day 14, and follow-up. Additionally, a serum pregnancy test will also be performed at baseline. 
Urine drug screen: The following drugs will be tested for: barbiturates, benzodiazepines, cocaine, cannabinoids, 
methadone, methamphetamines, morphine/opiates, phencyclidine, and tricyclic antidepressants. 
a Serum follicle-stimulating hormone tests will be completed as necessary. 
b Thyroid stimulating hormone tests will be completed at Investigator’s discretion. 
Blood and urine samples will be analyzed at a central laboratory facility. Urine samples will be performed and 
analyzed by dipstick at the study site; a microscopic analysis will be performed if the results of dipstick indicate 
abnormalities to be further investigated. All laboratory reports must be reviewed, signed, and dated by the 
Investigator. A legible copy of all reports must be filed with both the patient’s eCRF and medical record (source 
document) for that visit. Any laboratory test result considered by the Investigator to be clinically significant 
should be considered an AE (clinically significant AEs include those that require an intervention). Clinically 
significant abnormal values occurring during the study will be followed up until repeat test results return to 
normal, stabilize, or are no longer clinically significant. 
 
Further information on sample collection, processing and shipping can be found in the 
Laboratory Manual. 
12.6 Columbia Suicide Severity Rating Scale 
Two versions of the CSSRS are to be used in the study. The first is to be used at Screening and 
will assess lifetime suicidal ideation and behavior until that point (Baseline-Screening Form). 
Identification of active suicidal ideation will exclude the patient from enrollment in the study. 
At each subsequent visit, the follow-up CSSRS is used (Since Last Visit form) to assess suicidal 
ideation and behavior since the last visit. 
The CSSRS should be administered by a healthcare professional trained in its use. 


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12.7 Adverse Events 
12.7.1 
Adverse Events 
An AE is any symptom, physical sign, syndrome, or disease that either emerges after the patient 
signs the ICF or, if present at Screening, worsens after signing the ICF, regardless of the 
suspected cause of the event. All medical and psychiatric conditions (except those related to the 
indication under study) present at Screening will be documented in the medical history eCRF. 
Changes in these conditions and new symptoms, physical signs, syndromes, or diseases should 
be noted on the AE eCRF during the rest of the study. Clinically significant laboratory 
abnormalities should also be recorded as AEs. Surgical procedures that were planned before the 
patient enrolled in the study are not considered AEs if the conditions were known before study 
inclusion; the medical condition should be reported in the patient’s medical history. 
Patients will be instructed to report AEs at each study visit. All AEs are to be followed up until 
resolution or a stable clinical endpoint is reached. 
Each AE is to be documented on the eCRF with reference to date of onset, duration, frequency, 
severity, relationship to study drug, action taken with study drug, treatment of event, and 
outcome. Furthermore, each AE is to be classified as being serious or nonserious. Changes in 
AEs and resolution dates are to be documented on the eCRF. 
For the purposes of this study, the period of observation for collection of AEs extends from the 
time the patient gives informed consent until the follow-up visit. Follow-up of the AE, even after 
the date of therapy discontinuation, is required if the AE persists until the event resolves or 
stabilizes at a level acceptable to the Investigator. 
When changes in the intensity of an AE occur more frequently than once a day, the maximum 
intensity for the event should be noted. If the intensity category changes over a number of days, 
then those changes should be recorded separately (with distinct onset dates). 
The severity of AEs will be graded according to Table 3. 
Specific guidelines for classifying AEs by intensity and relationship to study drug are given in 
Table 3 and Table 4. 
Table 3. 
Classification of Adverse Events by Intensity 
MILD: An event that is easily tolerated by the patient, causing minimal discomfort and not interfering with 
everyday activities. 
MODERATE: An event that is sufficiently discomforting to interfere with normal everyday activities. 
SEVERE: An event that prevents normal everyday activities. 
 


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Table 4. 
Classification of Adverse Events by Relationship to Study Drug 
UNRELATED: This category applies to those AEs that are clearly and incontrovertibly because of extraneous 
causes (disease, environment, etc). 
UNLIKELY: This category applies to those AEs that are judged to be unrelated to the test drug but for which no 
extraneous cause may be found. An AE may be considered unlikely to be related to study drug if or when it 
meets 2 of the following criteria: (1) it does not follow a reasonable temporal sequence from administration of 
the test drug (2) it could readily have been produced by the patient’s clinical state, environmental or toxic 
factors, or other modes of therapy administered to the patient (3) it does not follow a known pattern of response 
to the test drug or (4) it does not reappear or worsen when the drug is readministered. 
POSSIBLY: This category applies to those AEs for which a connection with the test drug administration appears 
unlikely but cannot be ruled out with certainty. An AE may be considered possibly related if or when it meets 
2 of the following criteria: (1) it follows a reasonable temporal sequence from administration of the drug; (2) it 
could not readily have been produced by the patient’s clinical state, environmental or toxic factors, or other 
modes of therapy administered to the patient or (3) it follows a known pattern of response to the test drug. 
PROBABLY: This category applies to those AEs that the Investigator feels with a high degree of certainty are 
related to the test drug. An AE may be considered probably related if or when it meets 3 of the following 
criteria: (1) it follows a reasonable temporal sequence from administration of the drug (2) it could not be 
reasonably explained by the known characteristics of the patient’s clinical state, environmental or toxic factors, 
or other modes of therapy administered to the patient (3) it disappears or decreases on cessation or reduction in 
dose (note that there are exceptions when an AE does not disappear upon discontinuation of the drug yet 
drug-relatedness clearly exists; for example, as in bone marrow depression, fixed drug eruptions, or tardive 
dyskinesia); or (4) it follows a known pattern of response to the test drug. 
DEFINITELY: This category applies to those AEs that the Investigator feels are incontrovertibly related to test 
drug. An AE may be assigned an attribution of definitely related if or when it meets all of the following criteria: 
(1) it follows a reasonable temporal sequence from administration of the drug(2) it could not be reasonably 
explained by the known characteristics of the patient’s clinical state, environmental or toxic factors, or other 
modes of therapy administered to the patient (3) it disappears or decreases on cessation or reduction in dose and 
recurs with reexposure to drug (if rechallenge occurs); and (4) it follows a known pattern of response to the test 
drug. 
Abbreviation: AE, adverse event. 
 
12.7.2 
Adverse Events of Special Interest 
An AESI (serious or nonserious) is one of scientific and medical concern specific to the 
Sponsor’s product or program, for which ongoing monitoring and rapid communication by the 
Investigator to the Sponsor could be appropriate. Such an event might require further 
investigation in order to characterize and understand it.  
For the purposes of this study, the following AEs are classed as AESIs: 
• Vivid and/or unpleasant dreams 
• Difficulty initiating or maintaining sleep 
Such AESI should be recorded in the eCRF and reported to the medical monitor via email. 
12.7.3 
Serious Adverse Events 
An SAE is any untoward medical occurrence, in the view of either the Investigator or Sponsor, that: 
• Results in death 
• Is life-threatening 


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• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly/birth defect 
Other important medical events that may not be immediately life-threatening or result in death or 
hospitalization, based upon appropriate medical judgment, are considered SAEs if they are 
thought to jeopardize the patient and/or require medical or surgical intervention to prevent one of 
the outcomes defining an SAE. Serious AEs are critically important for the identification of 
significant safety problems; therefore, it is important to take into account both the Investigator’s 
and the Sponsor’s assessment. If either the Sponsor or the Investigator believes that an event is 
serious, the event must be considered serious and evaluated by the Sponsor for expedited 
reporting. 
12.7.4 
Serious Adverse Event Reporting 
An SAE occurring from the time informed consent is obtained, during the study, or within 
14 days of stopping the treatment must be reported to the 
 Safety and 
Pharmacovigilance group and will be communicated to the Sponsor. Any such SAE because of 
any cause, whether or not related to the study drug, must be reported within 24 hours of 
occurrence or when the Investigator becomes aware of the event. Notification can be made using 
the dedicated fax line or email for the 
 pharmacovigilance group: 
 
 
  
If the Investigator contacts the 
pharmacovigilance group by telephone, then a 
written report must follow within 24 hours and is to include a full description of the event and 
sequelae in the format detailed in the SAE reporting form. 
The event must also be recorded on the standard AE eCRF. Preliminary reports of SAEs must be 
followed up by detailed descriptions later on, including clear and anonymized photocopies of 
hospital case reports, consultant reports, autopsy reports, and other documents when requested 
and applicable. Serious AE reports must be made whether or not the Investigator considers the 
event to be related to the investigational drug. 
Appropriate remedial measures should be taken to treat the SAE, and the response should be 
recorded. Clinical, laboratory, and diagnostic measures should be employed as needed in order to 
determine the etiology of the problem. The Investigator must report all additional follow-up 
evaluations to the 
 Safety and Pharmacovigilance group within 24 hours of 
becoming aware of the additional information or as soon as is practicable. All SAEs will be 
followed up until the Investigator and Sponsor agree the event is satisfactorily resolved. 


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Any SAE that is not resolved by the end of the study or upon discontinuation of the patient’s 
participation in the study is to be followed up until it either resolves, stabilizes, returns to 
baseline values (if a baseline value is available), or is shown to not be attributable to the study 
drug or procedures. 
12.7.5 
Suspected Unexpected Serious Adverse Reactions 
Any AEs that meet all of the following criteria will be classified as suspected unexpected serious 
adverse reactions (SUSARs) and reported to the appropriate regulatory authorities in accordance 
with applicable regulatory requirements for expedited reporting: 
• Serious 
• Unexpected (i.e., the event is not consistent with the safety information in the 
Investigators Brochure) 
• There is at least a reasonable possibility that there is a causal relationship between the 
event and the study treatment 
The Investigator will assess whether an event is causally related to study treatment. The Sponsor 
(
 
) will consider the Investigator’s assessment and determine whether the event 
meets the criteria for being reportable as a 7-day or 15-day safety report. SUSARs that are fatal 
or life-threatening SUSARs must be reported to the regulatory authorities and the institutional 
review boards (IRBs; where required) within 7 days after the Sponsor (
) has 
first knowledge of them, with a follow-up report submitted within a further 8 calendar days. 
Other SUSARs must be reported to the relevant regulatory authorities and the IRBs within 
15 calendar days after the Sponsor (
) first has knowledge of them. 
The Sponsor (
) is responsible for reporting SUSARs and any other events 
required to be reported in an expedited manner to the regulatory authorities and for informing 
Investigators of reportable events, in compliance with applicable regulatory requirements within 
specific timeframes. Investigators will notify the relevant IRBs of reportable events within the 
applicable timeframes. 
12.7.6 
Pregnancy 
Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening, 
Baseline, and follow-up. After administration of study drug, any known cases of pregnancy in 
female patients or female partners of male patients will be reported until the patient completes or 
withdraws from the study. The pregnancy will be reported immediately by faxing/emailing a 
completed pregnancy report to the Sponsor (or designee) within 24 hours of knowledge of the 
event. The pregnancy will not be processed as an SAE; however, the Investigator will follow-up 
with the patient/patient partner until completion of the pregnancy and must assess the outcome in 
the shortest possible time but not more than 30 days after completion of the pregnancy. The 
Investigator should notify the Sponsor (or designee) of the pregnancy outcome by submitting a 
follow-up pregnancy report. If the outcome of the pregnancy involved spontaneous or 


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therapeutic abortion (any congenital anomaly detected in an aborted fetus is to be documented), 
stillbirth, neonatal death, or congenital anomaly, the Investigator will report the event by 
faxing/emailing a completed pregnancy report form to the Sponsor (or designee) within 24 hours 
of knowledge of the event. 
Upon discontinuation from the study, only those procedures that would not expose the patient to 
undue risk will be performed. The Investigator should also be notified of pregnancy occurring 
during the study but confirmed after completion of the study. In the event that a patient/patient 
partner is subsequently found to be pregnant after inclusion of the patient in the study, any 
pregnancy will be followed to term, and the status of mother and child will be reported to the 
Sponsor after delivery. 
12.7.7 
Overdose 
The Investigator must immediately (within 24 hours) notify the Sponsor medical monitor, by 
email, of any occurrence of overdose with study drug. An overdose is classed as the patient 
taking more than 1 tablet in a calendar day. 


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13 PHARMACOKINETICS 
13.1 Pharmacokinetic Sampling 
13.1.1 
Blood Samples 
Blood samples for PK analysis of SUVN-G3031 levels will be collected at the time points 
indicated in the Schedule of Assessments (Table 1). The actual date and time of each blood 
sample collection will be recorded. 
Details of PK blood sample collection, processing, storage, and shipping procedures are provided 
in a separate Laboratory Manual. 
13.2 Pharmacokinetic Analytical Methodology 
The concentration of study drug will be determined from the plasma samples using a validated 
analytical method. Details of the method validation and sample analysis will be included with the 
final clinical study report. 


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14 STATISTICAL ANALYSIS 
A SAP will be prepared after the protocol is approved. This document will provide further details 
regarding the definition of analysis variables and analysis methodology to address all study 
objectives. The SAP will serve as a complement to the protocol and supersedes it in case of 
differences. 
The statistical evaluation will be performed using SAS® software version 9.4 or higher 
(SAS Institute, Cary, NC). All data will be listed, and summary tables will be provided. 
Summary statistics will be presented by treatment group. For continuous variables, data will be 
summarized with the number of patients (n), mean, SD, standard error of mean, median, 
minimum, and maximum by treatment group. For categorical variables, data will be tabulated 
with the number and proportion of patients for each category by treatment group. 
An unblinded interim analysis is planned when approximately 50% of patients have completed 
14 days of treatment (Visit 3 completed). This interim analysis is for the purpose of sample size 
re-estimation, and futility will not be examined. Interim analysis will occur under the supervision 
of an independently charted DMC. See Section 7.1.4.  
14.1 Determination of Sample Size 
This study plans to randomize 114 patients, using 1:1:1 treatment allocation (stratified by at least 
30% each by reported cataplexy patient history, Na-1 or Na-2 respectively), 38 to each treatment 
group. Using an SD of 5.0, N = 38 randomized patients per group will provide 80% power, to 
detect a treatment difference over placebo of 3.5 points or greater on the MWT at a 2-sided 
Type I error level of 0.05, assuming a dropout rate of 10%. 
Because of the unknown prognostic importance of a history of cataplexy with EDS on study 
outcome, a stratification factor will be included based upon that clinical presentation. 
Stratification would be applied across the entire study, and not within an individual center, and 
will be reflected in the analytic model. The purpose of the a priori defined subgroup is for 
hypothesis generation. 
14.2 Analysis Populations 
Intent-to-Treat (ITT) Population 
The ITT population will include all patients who were randomized, received at least one dose of 
study drug, and had baseline and at least one post-baseline primary efficacy assessment. 
Safety Population 
The safety population will include all randomized patients who receive at least 1 dose of study 
treatment. The treatment group assignment in this population will be defined by the treatment 
actually received. This population will be used for the analysis of safety. 


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Per Protocol (PP) Population 
The PP population will be a subset of ITT consisting of those patients who complete 14 days 
treatment and had no major protocol deviation affecting the primary efficacy variable. All 
protocol deviations will be assessed and documented on a case-by-case basis before the database 
lock, and deviations considered to have a serious impact on the efficacy results will lead to the 
relevant patient being excluded from the PP set. Before database lock, potential patient 
exclusions from PP set will be reviewed by the Sponsor and documented in a patient evaluability 
document. 
Pharmacokinetic (PK) Population 
The PK population will include all patients who receive at least 1 dose of study treatment with 
sufficient postdose plasma concentration data. This population will be used for PK analysis. 
14.3 Efficacy Analysis 
All efficacy analyses will be performed using the ITT population. 
14.3.1 
Analysis of Primary Efficacy Endpoint 
The primary efficacy endpoint is the change from baseline in the mean total ESS score at 
Day 14. A successful study requires demonstration of statistically significant differences between 
the combined SUVN-G3031 doses (2 mg and 4 mg) group and the placebo group at endpoint for 
the ESS.  
The null (H0) and alternative (H1) hypotheses of the study are as follows:  
H0: SUVN-G3031 and placebo do not differ in their change from baseline in the mean 
total ESS score at Day 14. 
H1: SUVN-G3031 and placebo differ in their change from baseline in the mean total ESS 
score at Day 14. 
The primary endpoint will be analyzed using a mixed model repeated measures (MMRM) 
analysis that includes the mean total ESS score from baseline to 7 days through to 14 days. This 
method is the preferred approach to longitudinal analysis because it utilizes observed data 
efficiently. 
The model will include randomized treatment, visit and treatment-by-visit interaction as 
explanatory variables, stratification factor for cataplexy patient history (presence or absence) and 
baseline total ESS score as covariates. The participant effect will be assumed to be random, and 
an unstructured covariance structure will be assumed for within participant variation. The main 
comparison will be a contrast between treatment groups at 14 days. Least square mean changes 
will be estimated for SUVN-G3031 and placebo.  
This analysis will be repeated for the ITT and PP populations. 


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Various sensitivity analyses will be performed using an analysis of covariance (ANCOVA) and 
multiple imputation pattern mixture model to handle missing data. Estimands specification and 
sensitivity analyses details will be included in the SAP. 
14.3.2 
Analysis of Secondary Efficacy Endpoints 
The secondary efficacy endpoints for this study are: 
• Change from baseline in the mean CGI-S score related to EDS at Day 14 
• Change from baseline in the mean MWT score at Day 14 
To control the Type I error rate, the testing of secondary endpoints will be controlled using 
hierarchical testing methods. Thus, only if the primary endpoint is statistically significant, will 
the first listed secondary endpoint be tested. Likewise, the second listed secondary endpoint will 
only be tested if the first secondary endpoint is also statistically significant. 
The secondary endpoints will be analyzed analogous to the analysis of the primary efficacy 
endpoint, i.e., an MMRM using the ITT population with the same factors, except the baseline 
value for the respective variable will be used instead of baseline total ESS score. 
14.3.3 
Analysis of Exploratory Endpoints 
Continuous exploratory endpoints (listed below) will be analyzed in a similar fashion as the 
primary endpoint, i.e., an MMRM using the ITT population with the same factors, except the 
baseline value for the respective variable will be used instead of baseline total ESS score. 
• Change from baseline in the mean total ESS score at Day 7 
• Change from baseline in the mean CGI-S score related to EDS at Day 7 
• Change from baseline in the mean MWT score at Day 7 
• Change from baseline in the behavior of sleep diary parameters at Day 7 and Day 14 
(7-day average) 
• Changes in the behavior of the nocturnal overnight PSG assessments at Day 7 and 
Day 14 
• Change in MWT score, within each of the 4 MWT sessions within a single day (Day 7 
and Day 14) 
For binary assessments (listed below), a repeated measures responder analyses will use a 
generalized estimating equations with a logit link function and starting with an unstructured 
working correlation matrix. 
• The proportion of patients reporting CGI-C scores of 1 or 2 at Day 14 (EDS) 
• The proportion of patients reporting CGI-S scores related to EDS of 1 or 2 at Day 7 and 
Day 14 


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• Proportion of patients with improvement in the PGI-C score from baseline to Day 7 and 
Day 14 
• Analysis of all endpoints (except sleep diary parameters and nocturnal overnight PSG 
assessments) evaluating SUVN-G3031 2 mg or 4 mg compared with placebo 
• Additional exploratory endpoints may be included in the SAP 
Factors included in the model will be treatment group, a stratification factor for cataplexy patient 
history, visit, treatment-by-visit interaction, and baseline value as a covariate. Model estimates 
will be based on Wald statistics. 
Exploratory measures will also include the evaluation of associated features of narcolepsy 
through a sleep diary and measures collected as part of the nocturnal overnight PSG assessments 
at Day 7 and Day 14 using descriptive statistics. 
Further exploratory analyses will include each individual MWT session throughout the day in 
comparison to matched baseline sessions (morning, afternoon, or evening testing periods as 
defined within the protocol). 
14.4 Safety Analysis 
14.4.1 
Adverse Events 
All reported AEs will be coded using the most recent version of Medical Dictionary for 
Regulatory Activities (MedDRA). The incidence of TEAEs (events with onset dates on or after 
the start of the study drug) will be included in incidence tables. Events with missing onset dates 
will be included as treatment-emergent unless an incomplete date clearly indicates that the event 
started prior to the first study drug administration. If a patient experiences more than 
1 occurrence of the same AE, the occurrence with the greatest severity and the closest 
association with the study drug will be used in the summary tables. Serious AEs, AEs causing 
discontinuation and AESIs will be tabulated. All AEs will be listed by patient, along with 
information regarding onset, duration, relationship and severity to study drug, action taken with 
study drug, treatment of event, and outcome. 
14.4.2 
Laboratory Evaluations 
Descriptive statistics will be performed for those laboratory parameters on a continuous scale for 
the raw scores and change from baseline at each visit. Categorical results for urinalysis will be 
summarized using frequency tabulations. Abnormal values for each analyte will be determined 
using reference ranges provided by the central laboratory. All laboratory results will be listed 
including unscheduled visits. 
14.4.3 
Vital Signs 
Actual and change from baseline values in vital signs (body temperature, respiration rate, heart 
rate, and systolic and diastolic blood pressure) and body weight will be summarized for each 
scheduled visit. The corresponding listing will be provided. 


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14.4.4 
Electrocardiogram 
Change from baseline in the 12-Lead ECG results will be calculated and summarized along with 
the actual results for each scheduled visit. ECG data will also be listed. 
14.4.5 
Prior and Concomitant Medications 
All nonstudy medications will be classified using the dynamic version of the World Health 
Organization Drug Dictionary (WHODD). Coding includes the Anatomical Therapeutic 
Chemical (ATC) classification levels and preferred term.  
All medications administered and stopped prior to first dose of study drug are considered as prior 
medications. Any medications taken before the first dose and continued after the first dose or 
medications taken on or after the first dose of study drug are classified as concomitant 
medications. Concomitant medications will be summarized by the ATC levels and preferred 
term. All nonstudy medications will be listed. 
14.4.6 
Physical Examination 
Physical examination data (Normal/Abnormal) at each visit will be listed by body system. 
14.4.7 
Columbia Suicide Severity Rating Scale 
Columbia Suicide Severity Rating Scale data will be listed for all patients. 
14.4.8 
Patient Disposition 
All patients who discontinued from treatment will be listed and the reasons for discontinuation 
will be tabulated. 
14.4.9 
Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized using descriptive statistics. 
Demographics and informed consent data will be listed for all randomized patients. 
14.5 Pharmacokinetic Analysis 
The PK data will be summarized using descriptive statistics and all plasma concentration data 
will be listed using the PK population. 
14.6 Interim Analysis 
Because of uncertainty in the underlying assumption supporting the power calculation, an 
unblinded interim analysis is planned when approximately 50% of patients have completed 
14 days of treatment (Visit 3 completed) in order to increase the sample size if this deemed 
necessary and thus to increase the likelihood for a positive study.  
The unblinded interim analysis is for the purpose of sample size re-estimation, and futility will 
not be examined. Sample size re-estimation will be performed using conditional power 
calculations. In case of sample size increase the weighted Cui, Hung, Wang test-statistic will be 
used for the combination of the data prior to the interim analysis and after interim analysis. 
 
 


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The sample size re-estimation will permit a maximum of 57 additional patients (19 per treatment 
arm) to be randomized, and it will not permit a reduction in the initial sample size of 114 total 
patients. 
Unblinded interim analysis will be performed in a firewall-protected project folder by an 
independent unblinded DMC statistician. Unblinded results will remain confidential. Access to 
unblinded interim results and documentation will be limited to the DMC and unblinded DMC 
statistician. 
14.7 Data Monitoring Committee 
Unblinded interim analysis will occur under the supervision of an independently chartered DMC 
whose charter, composition, and methods of analysis and review will be presented separately 
prior to study initiation.
 
 
 
The DMC’s specific duties as well as statistical 
monitoring guidelines and procedures will be fully described in a DMC charter. 


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15 STUDY MANAGEMENT 
15.1 Approval and Consent 
15.1.1 
Regulatory Guidelines 
This study will be conducted in accordance with the accepted version of the Declaration of 
Helsinki and/or all relevant regulations, set forth in Parts 50, 56, 312, Subpart D, of Title 21 of 
the United States Code of Federal Regulations (CFR), in compliance with International Council 
for Harmonisation (ICH) and GCP guidelines and according to the appropriate regulatory 
requirements in the countries where the study will be conducted. 
15.1.2 
Institutional Review Board 
Conduct of the study must be approved by an appropriately constituted IRB. Approval is 
required for the study protocol, protocol amendments (if applicable), Investigator’s Brochure, 
ICFs, recruitment material and patient information sheets and other patient-facing material. 
15.1.3 
Informed Consent 
For each study patient written informed consent will be obtained before any protocol-related 
activities. As part of this procedure, the Principal Investigator (PI) or designee must explain 
orally and in writing the nature of the study, its purpose, procedures, expected duration, 
alternative therapy available, and the benefits and risks involved in study participation. The 
patient should be informed that he/she may withdraw from the study at any time, and the patient 
will receive all information that is required by local regulations and guidelines for ICH. The PI 
will provide the Sponsor or its representative with a copy of the IRB-approved ICF before the 
start of the study. 
15.2 Data Handling 
Any data to be recorded directly on the eCRFs (to be considered as source data) will be 
identified at the start of the study. Data reported on the eCRF that are derived from source 
documents should be consistent with the source documents, or the discrepancies must be 
explained. See also Section 15.3. 
Clinical data will be entered by site personnel on eCRFs for transmission to the Sponsor. Data on 
eCRFs transmitted via the web-based data system must correspond to and be supported by source 
documentation maintained at the study site, unless the study site makes direct data entry to the 
databases for which no other original or source documentation is maintained. In such cases, the 
study site should document which eCRFs are subject to direct data entry and should have in 
place procedures to obtain and retain copies of the information submitted by direct data entry. 
All study forms and records transmitted to the Sponsor must only include coded identifiers such 
that directly identifying personal information is not transmitted. The primary method of data 
transmittal is via the secure, internet-based electronic data capture (EDC) system maintained by 
 the EDC system is available to only authorized users via the study’s 
internet web site, where a user unique assigned username and password are required for access. 


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Any changes made to data after collection will be made through the use of the EDC system. 
Electronic CRFs will be considered complete when all missing and/or incorrect data have been 
resolved. 
15.3 Source Documents 
Source documents are considered to be all information in original records and certified copies of 
original records of clinical findings, observations, data, or other activities in a clinical study 
necessary for the reconstruction and evaluation of the study. The Investigator will provide direct 
access to source documents and/or source data in the facilitation of trial-related monitoring, 
audits, review by IRBs, and regulatory inspections. 
The Investigator/institution should maintain adequate and accurate source documents and trial 
records that include all pertinent observations on each of the site’s trial patients. Source data 
should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to 
source data should be traceable, not obscure the original entry, and be explained if necessary. 
15.4 Record Retention 
Study records and source documents must be preserved for at least 15 years after the completion 
or discontinuation of/withdrawal from the study, at least 2 years after the drug being studied has 
received its last approval for sale, or at least 2 years after the drug development has stopped, and 
in accordance with the applicable local privacy laws, whichever is the longer time period. 
The Investigator agrees to comply with all applicable federal, state, and local laws and 
regulations relating to the privacy of patient health information, including, but not limited to, the 
Standards for Individually Identifiable Health Information, 45 CFR, Parts 160 and 164 (the 
Health Insurance Portability Accountability Act of 1996 [HIPAA] Privacy Regulation).The 
Investigator shall ensure that study patient authorize the use and disclosure of protected health 
information in accordance with HIPAA Privacy Regulation and in a form satisfactory to the 
Sponsor. 
15.5 Monitoring 
The study will be monitored according to the monitoring plan to ensure that it is conducted and 
documented properly according to the protocol, GCP, and all applicable regulatory requirements. 
Monitoring visits, on-site and remote and contacts will be made at appropriate times during the 
study. The PI will assure he/she and adequate site personnel are available throughout the study to 
collaborate with clinical monitors. Clinical monitors must have direct access to source 
documentation in order to check the completeness, clarity, and consistency of the data recorded 
in the eCRFs for each patient. 
The Investigator will make available to the clinical monitor all source documents and medical 
records necessary to review protocol adherence and eCRFs. In addition, the Investigator will 
work closely with the clinical monitor and, as needed, provide them appropriate evidence that the 


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study is being conducted in accordance with the protocol, applicable regulations, and GCP 
guidelines. 
15.6 Quality Control and Quality Assurance 
The Sponsor or its designee will perform the quality assurance and quality control activities of 
this study; however, responsibility for the accuracy, completeness, security, and reliability of the 
study data presented to the Sponsor lies with the Investigator generating the data. 
The Sponsor will arrange audits as part of the implementation of quality assurance to ensure that 
the study is being conducted in compliance with the protocol, standard operating procedures, 
GCP and all applicable regulatory requirements. Audits will be independent of and separate from 
the routine monitoring and quality control functions. Quality assurance procedures will be 
performed at study sites and during data management to assure that safety and efficacy data are 
adequate and well documented. 
15.7 Protocol Amendment and Protocol Deviation 
15.7.1 
Protocol Amendment 
Amendments to the protocol that entail corrections of typographical errors, clarifications of 
confusing wording, changes in study personnel, and minor modifications that have no effect on 
the safety of patient or the conduct of the study will be classed as administrative amendments 
and will be submitted to the IRB for information only. The Sponsor will ensure that 
acknowledgement is received and filed. Amendments that are classed as substantial amendments 
must be submitted to the appropriate regulatory authorities and the IRBs for approval and will 
not be implemented at sites until such approvals are received other than in the case of an urgent 
safety measure. 
15.7.2 
Protocol Deviations 
Should a protocol deviation occur, the Sponsor must be informed as soon as possible. Protocol 
deviations and/or violations and the reasons they occurred will be included in the clinical study 
report. Reporting of protocol deviations to the IRB and in accordance with applicable regulatory 
authority mandates is an Investigator responsibility. 
15.8 Ethical Considerations 
This study will be conducted in accordance with this protocol, the accepted version of the 
Declaration of Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 312, 
Subpart D, of Title 21 of the CFR; Annex 1, D, 17 (a); and in compliance with GCP guidelines. 
Institutional Review Boards will review and approve this protocol and the ICF. All patients are 
required to give written informed consent before participation in the study. 


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15.9 Financing and Insurance 
Before the study commences, the Sponsor (or its designee) and the Investigator (or the 
institution, as applicable) will agree on costs necessary to perform the study. This agreement will 
be documented in a financial agreement that will be signed by the Investigator (or the institution 
signatory) and the Sponsor (or its designee). 
The Investigator is required to have adequate current insurance to cover claims for negligence 
and/or malpractice. The Sponsor will provide no-exclusion insurance coverage for the clinical 
study as required by national regulations. 
15.10 Publication Policy/Disclosure of Data 
Both the use of data and the publication policy are detailed within the clinical study agreement. 
Intellectual property rights (and related matters) generated by the Investigator and others 
performing the clinical study will be subject to the terms of a clinical study agreement that will 
be agreed between the institution and the Sponsor or their designee. With respect to such rights, 
the Sponsor or its designee will solely own all rights and interests in any materials, data, and 
intellectual property rights developed by Investigators and others performing the clinical study 
described in this protocol, subject to the terms of any such agreement. In order to facilitate such 
ownership, Investigators will be required to assign all such inventions either to their institution or 
directly to the Sponsor or its designee, as will be set forth in the clinical study agreement. 


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Harsh JR, Hayduk R, Rosenberg R, et al. The efficacy and safety of armodafinil as treatment for 
adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin. 2006; 
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Inoue Y, Uchiyama M, Umeuchi H, et al. Optimal dose determination of enerisant (TS-091) for 
patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC 
Psychiatry. 2022;22(1):141.  
Johns MW. Sensitivity and specificity of the multiple sleep latency test (MSLT), the 
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Littner MR, Kushida C, Wise M, et al. Practice parameters for clinical use of the multiple sleep 
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Pillen S, Pizza F, Dhondt K, Scammell TE, Overeem S. Cataplexy and its mimics: clinical 
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Wozniak R, Quinnell T. Unmet needs of patients with narcolepsy: perspectives on emerging 
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17 APPENDICES 
Appendix 1 describes the contraception guidelines applicable for this study. 
Appendix 2 describes prohibited and restricted medications in this study. 
Appendix 3 describes caffeine dosages of common drinks. 


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Appendix 1. 
Contraception Guidelines 
Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must 
use at least 2 highly effective methods of contraception during the study and for 30 days after the 
last dose of study treatment.  
A woman is considered to be a WOCBP (fertile) after menarche and until becoming postmenopausal, 
unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 
12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in 
the postmenopausal range may be used to confirm a postmenopausal state in women not using 
hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of 
amenorrhea, a single FSH measurement is insufficient.  
A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. 
Highly effective methods of contraception are those which have a failure rate of <1% (when 
implemented consistently and correctly) and include: 
• Combined (containing estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (administration may be oral, intravaginal, or transdermal) 
• Progestogen-only hormonal contraception associated with inhibition of ovulation 
(administration may be oral, injectable, or implantable) 
• Intrauterine device 
• Intrauterine hormone-releasing system 
• Bilateral tubal ligation or occlusion 
• Vasectomy (provided that the male has a medical assessment of surgical success) 
• Sexual abstinence (defined as refraining from heterosexual intercourse during the entire 
period of risk in relation to the duration of the clinical trial, in line with the preferred and 
usual lifestyle of the patient) 
All patients will be strongly advised that they (or the female partners of male patients) should not 
become pregnant while on study treatment or for 30 days after the last dose. A female patient 
will be advised that she must report immediately to the study site for pregnancy testing and 
appropriate management in the event that she may be pregnant. 
 
 
Reference 
Heads of Medicines Agencies. Clinical Trial Facilitation Group page. Recommendations related 
to contraception and pregnancy testing in clinical trials. September 2014. 
http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-
About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf. Accessed 
April 05, 2019. 


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Appendix 2. 
Prohibited or Restricted Medications 
Restriction Rationale 
Restriction 
Medication Examples 
As required anxiolytics may cause erratic 
variation/addiction patterns which confound 
study assessments. 
Investigator has discretion to limit enrollment, on a 
case-by case basis. This must be approved by the 
Medical Monitor and a rationale given for its use. 
Primarily benzodiazepines 
Sleep aids or stimulants that affect efficacy 
assessment 
Washout completed 7 days prior to randomization 
Methylphenidate, dextroamphetamine, 
methamphetamine, modafinil and armodafinil, 
pseudoephedrine, amphetamines, pemoline, trazodone, 
hypnotics, benzodiazepines, barbiturates, opioids, 
Isocarboxazid, phenelzine, selegiline, rasagiline, 
tranylcypromine, bupropion 
Marijuana/CBD/cannabinoids can affect sleep, 
mood, behavior 
Use of medically prescribed cannabinoids without 
euphoric or soporific effects may be allowed by the 
Medical Monitor but must be avoided 48 h prior to 
assessments. Other substances are not permitted. 
Marijuana/CBD/cannabinoids 
Adjunctive pharmacotherapy directed against 
cataplexy confounds study treatment  
Washout completed 14 days before randomization 
Including but not limited to selective serotonin 
reuptake inhibitors, serotonin and norepinephrine 
reuptake inhibitors, tricyclic antidepressants, 
monoamine oxidase inhibitors, anticonvulsant agents, 
sodium oxybate, pitolisant 
Medications with subtle sedating effects may 
be permitted with PI discretion 
Principal Investigator has discretion to limit 
enrollment on a case-by-case basis to those with mild 
conditions, with stable use (≥ 3 months), not likely to 
require treatment changes during the trial 
Beta blockers are allowed to be continued, provided 
they are used at a stable dose 


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Appendix 3. 
Caffeine Dosages for Common Drinks 
Brewed Green Tea – Please use the same content for Brewed Black Tea  
• Short (8 oz, 237 ml) 25 mg  
• Tall (12 oz, 355 ml) 55 mg  
• Grande (16 oz, 473 ml) 80 mg  
• Venti (20 oz, 591 ml) 110 mg  
 
Brewed Coffee  
• Short (8 oz, 237 ml) 175 mg  
• Tall (12 oz, 355 ml) 260 mg  
• Grande (16 oz, 473 ml) 330 mg  
• Venti (20 oz, 591 ml) 410 mg  
 
Espresso (and espresso drinks such as lattes, cappuccinos, etc)  
• Espresso (single shot) 75 mg  
• Double espresso 150 mg  
 
Energy Drinks  
• Red Bull™ 80 mg  
• Monster™ 160 mg  
• Rockstar™ 160 mg  
• Full Throttle™ 144 mg  
• No Fear™ 174 mg  
• Amp™ 75 mg  
• Tab Energy™ 95 mg  
• Jolt Cola™ 280 mg  
• NOS™ 250 mg  
• VitaminWater™ Energy Citrus 50 mg  
 


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Classic Sodas  
• Coca cola™ 35 mg  
• Pepsi cola™ 38 mg  
• Dr. Pepper™ 41 mg  
• Mountain Dew™ 54 mg  
 
5-hour Energy Drinks 
• 5-hour Energy® 200 mg  
• Extra strength 5-hour Energy® 230 mg  
 
 
References 
Caffeine contents of tea, coffee, and espresso drinks are based on data from Starbucks: 
https://globalassets.starbucks.com/assets/01D7B4F4783F4793A5113FAF415BA8D6.pdf 
Caffeine contents of energy drinks are based on Table 1 from: 
Reissig CJ, Strain EC, Griffiths RR. Caffeinated energy drinks--a growing problem. Drug 
Alcohol Depend. 2009;99(1-3):1-10. 
Caffeine contents of 5-hour Energy products are based on data from the manufacturer: 
http://5hourenergy.com/facts/ingredients/. Accessed April 19, 2019. 

SAP_001.pdf: 
 
 
Statistical Analysis Plan (SAP) 
 
Protocol Title: A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter 
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and 
Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in 
Patients with Narcolepsy with and without Cataplexy 
Protocol Number: CTP2S13031H3  
NCT04072380  
Date: 05 September 2023 


Statistical Analysis Plan 
Sponsor: Suven Life Sciences;  Protocol No.: CTP2S13031H3 
 
This document is confidential. 
SAP Version: 5.0 (05-Sep-2023) 
Page 1 of 62 
Statistical Analysis Plan  
 
Version 5.0 – 05Sep2023  
 
Sponsor Name: Suven Life Sciences 
 
Protocol Number: CTP2S13031H3 
 
Protocol Title: A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate 
the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to 
Placebo in Patients with Narcolepsy with and without Cataplexy 
 
 
Protocol Version and Date: Version 4.0 – 16 Aug 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notice of Confidential and Proprietary Information: 
The information contained in this document is confidential belonging to Suven Life Sciences. Acceptance of 
this document constitutes agreement by the recipient that no information contained herein will be published 
or disclosed without prior written authorization from an official of Suven Life Sciences. However, this 
document may be disclosed to appropriate Institutional Review Board and Ethics Committees or duly 
authorized representatives of a national regulatory authority under the condition that they are requested to 
keep it confidential. In the event of an actual or suspected breach of this obligation, 
 should be 
notified promptly. 
 








Statistical Analysis Plan 
Sponsor: Suven Life Sciences;  Protocol No.: CTP2S13031H3 
 
 
 
This document is confidential. 
 
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Table of Contents 
Revision History .......................................................................................................................... 2 
Approvals .................................................................................................................................... 4 
1. 
Glossary of Abbreviations ................................................................................................... 8 
2. 
Purpose ............................................................................................................................ 10 
2.1. 
Responsibilities .............................................................................................................10 
2.2. 
Timings of Analyses ......................................................................................................10 
2.3. 
Changes based on Protocol Amendment v4 ..................................................................10 
3. 
Study Objectives .............................................................................................................. 12 
3.1. 
Primary Objective ..........................................................................................................12 
3.2. 
Secondary Objective(s) .................................................................................................12 
3.3. 
Exploratory Objective(s) ................................................................................................12 
3.4. 
Brief Description ............................................................................................................12 
3.5. 
Subject Selection ...........................................................................................................13 
3.5.1. 
Inclusion Criteria .............................................................................................13 
3.5.2. 
Exclusion Criteria ............................................................................................15 
3.6. 
Determination of Sample Size .......................................................................................16 
3.7. 
Treatment Assignment and Blinding ..............................................................................17 
3.8. 
Administration of Study Medication ................................................................................17 
3.9. 
Study Procedures ..........................................................................................................18 
4. 
Study Endpoints ............................................................................................................... 21 
4.1. 
Primary Efficacy Endpoint ..............................................................................................21 
4.2. 
Secondary Efficacy Endpoints .......................................................................................21 
4.3. 
Exploratory Endpoints ...................................................................................................21 
4.4. 
Pharmacokinetic Endpoints ...........................................................................................21 
4.5. 
Pharmacodynamic Endpoints ........................................................................................21 
4.6. 
Safety Endpoints ...........................................................................................................21 
4.7. 
Health-economics Endpoints .........................................................................................22 
4.8. 
Other Endpoints ............................................................................................................22 
5. 
Analysis Population .......................................................................................................... 23 
5.1. 
Safety Population ..........................................................................................................23 
5.2. 
ITT Population 23 
5.3. 
Per Protocol (PP) Population .........................................................................................23 


Statistical Analysis Plan 
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5.4. 
Pharmacokinetic (PK) Population ..................................................................................23 
5.5. 
Pharmacodynamic Population .......................................................................................23 
5.6. 
Other Analysis Population .............................................................................................23 
5.7. 
Protocol Deviations........................................................................................................23 
6. 
General Aspects for Statistical Analysis ........................................................................... 24 
6.1. 
General Methods ...........................................................................................................24 
6.2. 
Key Definitions ..............................................................................................................24 
6.2.1. 
Baseline ..........................................................................................................24 
6.2.2. 
Body Mass Index ............................................................................................24 
6.2.3. 
Change from Baseline .....................................................................................24 
6.2.4. 
Treatment Accountability and Compliance ......................................................24 
6.2.5. 
Days of Study Termination ..............................................................................25 
6.2.6. 
Study Completion ............................................................................................25 
6.2.7. 
Duration of AE .................................................................................................25 
6.2.8. 
Prior/Concomitant Medication .........................................................................25 
6.2.9. 
Study Day 1 ....................................................................................................25 
6.3. 
Missing Data 26 
6.3.1. 
Missing Dates .................................................................................................26 
6.3.2. 
Missing values ................................................................................................26 
6.4. 
Visit Windows 26 
6.5. 
Pooling of Centers .........................................................................................................26 
6.6. 
Examination of Subgroups .............................................................................................26 
7. 
Demographic, Other Baseline Characteristics and Medication ......................................... 27 
7.1. 
Subject Disposition and Withdrawals .............................................................................27 
7.2. 
Demographic and Other Baseline Characteristics .........................................................27 
7.3. 
Medical History and Disease History .............................................................................27 
7.4. 
Prior and Concomitant medication .................................................................................27 
8. 
Efficacy Evaluation ........................................................................................................... 29 
8.1. 
Primary Efficacy Endpoint and Analysis (Primary Estimand) .........................................29 
8.2. 
Sensitivity and Supportive Analyses ..............................................................................30 
8.3. 
Sensitivity and Robustness Analysis .............................................................................31 
8.4. 
Secondary Efficacy Endpoint(s) and Analyses (Secondary Estimands) .........................31 


Statistical Analysis Plan 
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8.5. 
Analysis of Exploratory Endpoints .................................................................................32 
9. 
Analysis of Pharmacokinetics ........................................................................................... 34 
10. 
Safety Evaluation ............................................................................................................. 35 
10.1. Extent of Exposure ........................................................................................................35 
10.2. Treatment Compliance ..................................................................................................35 
10.3. Adverse Events (AEs) ...................................................................................................35 
10.4. Laboratory Evaluations ..................................................................................................37 
10.5. Vital Signs 
38 
10.6. Electrocardiogram (ECG) ..............................................................................................38 
10.7. Physical Examination ....................................................................................................38 
10.8. Columbia-Suicide Severity Rating Scale (C-SSRS) .......................................................38 
11. 
Interim Analyses and Implementing of Adaptive Design ................................................... 39 
11.1. Interim Analysis with Unblinded Sample Size Re-estimation .........................................39 
11.2. Brief Description of CHW ...............................................................................................40 
11.3. Conditional Power .........................................................................................................41 
11.4. Statistical outputs to be generated .................................................................................41 
12. 
Changes from Analysis Planned in Protocol ..................................................................... 43 
13. 
Reference List .................................................................................................................. 44 
14. 
Programming Considerations ........................................................................................... 45 
14.1. General Considerations .................................................................................................45 
14.2. Table, Listing, and Figure Format ..................................................................................45 
14.3. General 
45 
14.3.1. 
Headers ..........................................................................................................45 
14.3.2. 
Display Titles...................................................................................................46 
14.3.3. 
Column Headers .............................................................................................46 
14.3.4. 
Body of the Data Display .................................................................................46 
15. 
Quality Control ................................................................................................................. 50 
16. 
Index of Tables and Figures ............................................................................................. 51 
17. 
Index of Listings ............................................................................................................... 57 
18. 
Shells ............................................................................................................................... 59 
19. 
Appendices ...................................................................................................................... 60 






Statistical Analysis Plan 
Sponsor: Suven Life Sciences;  Protocol No.: CTP2S13031H3 
 
 
 
This document is confidential. 
 
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2. 
Purpose 
The purpose of this statistical analysis plan (SAP) is to ensure that the data listings, summary tables 
and figures which will be produced, and the statistical methodologies that will be used, are complete 
and appropriate to draw valid conclusions regarding the study objectives described under Suven Life 
Sciences Protocol CTP2S13031H3 titled “A Phase 2, Double-blind, Placebo-controlled, Parallel-group, 
Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 
mg SUVN-G3031 Compared to Placebo in Patients with Narcolepsy with and without Cataplexy”, 
Version 4.0 dated 16 Aug 2023. 
2.1. Responsibilities 
 will perform the statistical analyses and is responsible for the production and quality 
control of all tables, figures and listings.  
2.2. Timings of Analyses 
The final analysis of safety and efficacy is planned after all subjects complete the final study visit or 
terminate early from the study for the respective part. Unless otherwise specified, the analysis includes 
all data collected in the database through the time of the database lock.   
An independent Data Monitoring Committee (DMC) will review descriptive summaries of accumulating 
safety and subject disposition data after 25%, and 50% of subjects have been completed treatment. 
Further description of the DMC analyses can be found in the DMC charter Version 1.0 dated 30-Sep-
2019. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ad hoc meetings will be at the discretion of the committee or Suven (e.g. in the event of unexpected 
SAEs or if consultation with additional expert consultants is required). 
An interim analysis to evaluate sample size assumptions will be conducted when approximately 50% 
of subjects have completed 14 days of treatment. Sample size re-estimation will be performed as part 
of the interim analysis. An unblinded team from 
biostatistics will perform the analyses 
as described in Section 11.1 of this SAP to maintain the blinding of the study. 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis Plan 
Sponsor: Suven Life Sciences;  Protocol No.: CTP2S13031H3 
 
 
 
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Statistical Analysis Plan 
Sponsor: Suven Life Sciences;  Protocol No.: CTP2S13031H3 
 
 
 
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3. 
Study Objectives 
3.1. 
Primary Objective 
To evaluate the efficacy of SUVN-G3031 compared with placebo as measured by the change in total 
Epworth Sleepiness Scale (ESS) score. 
3.2. 
Secondary Objective(s) 
To evaluate the efficacy of SUVN-G3031 compared with placebo as measured by an improvement in 
the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness 
(EDS) and Maintenance of Wakefulness Test (MWT) score. 
3.3. 
Exploratory Objective(s) 
• 
To evaluate the efficacy of SUVN-G3031 compared with placebo as measured by an 
improvement in the MWT score, at each of 4 planned 30-minute sessions per test day  
• 
To evaluate the change in Clinical Global Impression of Change (CGI-C) score with regard to 
EDS  
• 
To evaluate the change in CGI-S score with regard to EDS  
• 
To evaluate the change in Patient Global Impression – Change (PGI-C) score  
• 
To evaluate the change in Daily Sleep Diary  
• 
To evaluate the change in nocturnal overnight polysomnography (PSG) assessments  
• 
To evaluate the change in total ESS score 
3.4. 
Brief Description 
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the 
safety, tolerability, PK, and efficacy of 2 mg and 4 mg SUVN-G3031 compared with placebo in 
subjects with narcolepsy with and without cataplexy. Subjects will be randomized at a ratio of 1:1:1 to 
2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Subjects will be stratified based on whether they 
have narcolepsy with or without cataplexy (Na-1 or Na-2, respectively). 
Each subject will receive study drug once daily, in a tablet formulation, for 14 days. Enough subjects 
will be screened to enable 114 subjects to be enrolled (38 per treatment group). A single, unblinded, 
interim analysis will be undertaken when approximately 50% of subjects have completed 14 days of 
treatment; this analysis will enable sample size re-estimation to occur if appropriate. A maximum of 57 
additional subjects (19 subjects per treatment arm) will be enrolled to generate a total maximum study 
population of 171 subjects. 
Subjects will be enrolled at approximately 65 sites in the United States and Canada. It is anticipated it 
will take 12 months to complete enrollment and 13 months to complete the entire study. 
Each subject will complete 3 periods: Screening, Dosing Period and Safety Follow-up. 
Screening: Subjects who have provided written informed consent will be screened up to 28 days 


Statistical Analysis Plan 
Sponsor: Suven Life Sciences;  Protocol No.: CTP2S13031H3 
 
 
 
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before enrollment. Eligible subjects will complete a washout period of ≥ 14 days for all agents targeting 
cataplexy and ≥ 7 days for all stimulants targeting EDS. 
Dosing Period: Once these washout periods have been completed, subjects will attend the clinic for 
randomization and baseline (Day 0) assessments; subjects will provide a blood sample for PK 
analysis. Following completion of baseline (Day 0) assessments, study drug will be dispensed to 
subjects and they will take their first dose the next day (Day 1); subjects will receive enough study drug 
to last until the next visit at Day 7. On Day 7 (±1 day), subjects will attend the clinic for an outpatient 
visit, when efficacy and safety assessments will be undertaken. Subjects will provide a blood sample 
for PK analysis at the estimated trough (just prior to dosing) and at the estimated maximum plasma 
concentration of SUVN-G3031 (3 ± 0.5 hours post-dosing). Subjects will be dispensed enough study 
drug to last until the next visit at Day 14. On Day 14 (±1 day), subjects will attend the clinic for an 
outpatient visit, where efficacy and safety assessments will be undertaken. They will provide a sample 
for PK analysis as per the Day 7 visit. 
Safety Follow-up: A final safety follow-up visit will be performed at Day 21 (±1 day). All visits will be 
outpatient visits and subjects will be enrolled in the study for a maximum of 49 days (7 weeks) from the 
start of the screening period. 
Flowchart: A study schematic can be seen below. 
 
Abbreviations: ESS, Epworth Sleepiness Scale; MWT, Maintenance of Wakefulness Test. 
3.5. 
Subject Selection 
3.5.1. Inclusion Criteria 
Individuals must meet all of the following criteria to be included in the study: 
1. Must be between the ages of 18 to 65 years (adult), inclusive. 


Statistical Analysis Plan 
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2. Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification 
of Sleep Disorders (3rd Edition) criteria for the diagnosis of narcolepsy (new or previously 
diagnosed). 
3. Have undergone an Multiple Sleep Latency Test (MSLT) study showing an MSLT of ≤ 8 minutes 
with 2 or more SOREMPs performed according to standard techniques, with substitution of 1 of 
the required SOREMPs on MSLT with 1 obtained from the preceding nocturnal PSG, performed at 
the time of diagnosis. No other potential cause for EDS must have been identified during the 
preceding nocturnal PSG. If the study site is unable to obtain the MSLT diagnoses, the MSLT may 
be performed to confirm diagnoses upon Sponsor and medical monitor approval. 
4. An ESS score of ≥ 12; and mean MWT time of < 12 minutes across the first 4 sessions at 
baseline. An ESS score of ≥ 12 for eligibility is only required at the Baseline visit. An ESS score of 
< 12 at Screening due to concomitant medications will be subjected to PI’s discretion for eligibility. 
5. Must have a body mass index ranging from 18 to < 45 kg/m2. 
6. Negative urine drug screen (UDS) at the Screening and Baseline (Visit 1) visits. 
• 
A positive UDS at Screening can be repeated up to Day -1; however, a negative UDS is 
required prior to Day 0 (Baseline visit), and a second negative UDS is required on Day 0 
(Baseline visit). 
• 
A positive UDS at Screening due to concomitant medications will be subject to PI’s 
discretion for eligibility. 
7. All patients must agree to remain free of alcohol and illicit drugs from Screening and until the 
Safety Follow-up visit. 
8. All male subjects who are sexually active and not surgically sterilized must agree to use a condom 
with or without spermicide, in addition to any birth control used by their partner during the study 
until 1 month after the final dose of investigational product (IP).  
9. Before randomization, a woman must be either not of childbearing potential or of childbearing 
potential practicing highly effective methods of birth control. 
• 
“Not of childbearing potential” is defined as a subject who is postmenopausal (> 45 years of 
age with amenorrhea for at least 12 months); permanently sterilized (e.g., tubal occlusion, 
hysterectomy, bilateral salpingectomy); or otherwise is incapable of pregnancy, and 
müllerian agenesis). 
• 
“Of childbearing potential” and practicing a highly effective method of birth control is defined 
as a subject following regulations consistent with the use of birth control methods for 
subjects participating in clinical studies. A highly effective method of birth control is a method 
with low user dependency that results in a low failure rate (i.e., less than 1% per year) when 
used consistently and correctly. No exhaustive examples of highly effective methods 
include: e.g., established use of oral, injected, or implanted hormonal methods of 
contraception; placement of an intrauterine device or intrauterine system; barrier methods: 
condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or 
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner 
sterilization (the vasectomized partner should be the sole partner for that subject), or male 
partner is using condoms with spermicide; practicing true abstinence (the preferred and 
usual lifestyle of the subject). Two forms of effective methods of birth control must be used 
during the study and for 1 month after the last dose of IP. 
10. Willingness to complete the study protocol with full compliance with procedures and sign an 
informed consent form (ICF). 


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3.5.2. Exclusion Criteria 
Individuals meeting any of the following criteria at Screening or baseline are ineligible to participate in 
this study: 
1. Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of < 6 h and 
habitual bedtime past 1 AM as determined by sleep diary entries. 
2. Use of any investigational therapy within the 30-day period prior to enrollment. 
3. Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline 
assessments and during the course of the trial. (See protocol APPENDIX 3 for caffeine dosage 
definitions). 
4. Nicotine dependence that has an effect on sleep (e.g., a subject who routinely awakens at night to 
smoke). 
5. Use of concurrent medications prescribed to treat narcolepsy or any indication as specified 
including stimulants, antidepressants and sodium oxybate before Baseline and until the Safety 
Follow-up visit, as specified in protocol APPENDIX 2. 
6. Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any other 
cause of daytime sleepiness. If Investigator confirms that any of the following syndromes are not 
clinically significant to the extent that it is causing sleep disturbance, this subject may be permitted 
at the Investigator’s discretion. 
• 
Obstructive sleep apnea, or individuals requiring continuous positive airway pressure 
(obstructive sleep apnea noted during nocturnal PSG should be queried).  
• 
Periodic limb movement disorder (periodic limb movements noted during nocturnal PSG 
should be queried). 
• 
Other clinically significant disorders which cause sleep disruption (e.g., chronic pain 
disorder, chronic or untreated insomnia, clinically significant levels of gastroesophageal 
reflux disease, asthma, neuropathy, or other chronic pain disorders such as osteoarthritis or 
degenerative joint disease). 
• 
Hypothyroidism requires Investigator assessment to determine whether it contributes to 
interrupted or poor sleep, (i.e., causing daytime somnolence). 
• 
Parasomnias. 
• 
Significant nocturia. 
7. Clinically significant ECG abnormalities. Subjects are excluded with a screening ECG PR interval 
of ≥ 300 msec, QRS interval ≥ 200 msec, or Fridericia's correction of QT interval ≥ 450 msec for 
men and ≥ 470 msec for women obtained after 3-minute rest in a supine position using a digital 
ECG. Abnormal results for ECGs should be repeated once at screening with 3 consecutive ECG 
recordings to ensure reproducibility of the abnormality before excluding a subject based on the 
exclusion criteria. Each ECG recording should be taken approximately 5 minutes apart (the ECG 
result reported would be evaluated at each time point). A subject will be excluded if the QTcF is 
≥450 msec in men and ≥470 msec in women for 2 of the 3 time points of the ECGs done, unless 
due to ventricular pacing. If only 1 ECG time point has a QTcF of ≥450 msec in men and ≥470 
msec in women, and this is not reproduced at either of the other 2 time points, the subject can be 
included in the trial. 
8. Concurrent use of sedating agents such as hypnotics, tranquilizers, sedating antihistamines, 
antipsychotics, benzodiazepines, anticonvulsants, clonidine or tricyclic antidepressants which have 
H1-antihistamine properties (clomipramine, protriptyline) before Baseline and until the Safety 
Follow-up visit, as specified in protocol APPENDIX 2.  


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9. History of (within past 3 months) or current substance use disorder involving illicit drugs, alcohol, 
or marijuana, as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and 
non-disordered use of alcohol and recreational drugs. 
10. History or presence of any unstable medical condition or neurological disorder which may affect 
the subject’s safety or stability (such as serious cardiovascular disorder, moderate or severe 
gastrointestinal abnormalities, hepatic disorder or renal abnormalities, hepatitis C, hepatitis B, 
human immunodeficiency virus positive status, history of epilepsy, significant head injury, history 
of intracranial surgery, or malignancy in past 5 years).  
11. Subjects with preplanned surgeries requiring general anesthesia throughout the duration of the 
trial. 
12. Severe, unstable psychiatric illness including a diagnosis of bipolar disorder, schizophrenia or 
psychotic disorder in the subject’s lifetime, according to DSM-5 criteria. Subjects with severe or 
uncontrolled depression that, in the judgment of the Investigator, makes the subject inappropriate 
for entry into the study or which will require new onset of treatment during the course of the trial.  
Subjects who are at significant potential suicidal risk are determined by: 
• 
Subjects who answer “Yes” on the C-SSRS Suicidal Ideation Item 4 (active suicidal ideation 
with some intent to act, without specific plan) and whose most recent episode meeting 
criteria for this C-SSRS Item 4 occurred within the last 6 months; or 
• 
Subjects who answer “Yes” on the C-SSRS Suicidal Ideation Item 5 (active suicidal ideation 
with specific plan and intent) and whose most recent episode meeting criteria for this C-
SSRS Item 5 occurred within the last 6 months; or 
• 
Subjects who answer “Yes” on any of the 5 C-SSRS Suicidal Behavior Items (actual 
attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose 
most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items 
occurred within the last 2 years; or 
• 
Subjects who, in the opinion of the investigator, present a serious risk of suicide. 
13. An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts 
sleep patterns. 
14. In the opinion of the Investigator, it would be unsafe for a subject to stop taking any wake 
promoting agent for more than 4 weeks. The subject’s occupation (e.g., requirement for driving) 
may need to be considered. 
3.6. 
Determination of Sample Size 
Sample size for the MWT which was the primary efficacy in the study until the change in primary 
efficacy endpoint (refer to section 2.3): This study plans to randomize 114 subjects, using 1:1:1 
treatment allocation (stratified by atleast 30% each by reported cataplexy subject history, Na-1 or Na-2 
respectively), 38 to each treatment group. Using an SD of 5.0, N = 38 randomized subjects per group 
will provide 80% power, to detect a treatment difference over placebo of 3.5 points or greater on the 
MWT at a 2-sided Type I error level of 0.05, assuming a dropout rate of 10%. 
Because of the unknown prognostic importance of a history of cataplexy with EDS on study outcome, 
a stratification factor will be included based upon that clinical presentation. Stratification would be 
applied across the entire study, and not within an individual center, and will be reflected in the analytic 
model. The purpose of the a priori defined subgroup is for hypothesis generation.  
Based on the unblinded interim analysis results sample size was re-calculated to maximum of 171 
subjects (57 to each treatment group) on mean MWT as primary efficacy endpoint.  


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3.7. 
Treatment Assignment and Blinding 
Subjects will be randomized to the 3 study treatments (2 mg SUVN-G3031, 4 mg SUVN-G3031 and 
Placebo) in a 1:1:1 ratio. This randomization will be stratified based on whether they have narcolepsy 
with or without cataplexy (Na-1 or Na-2), respectively. 
Subjects will be randomized using an interactive response technology (IRT). The randomization 
number generated should be entered into the eCRF. 
This is a double-blind study. Tablets will be provided, pre-dispensed in blinded study kits. All tablets 
will be identical in appearance and size. 
According to the randomization schedule as indicated in the Schedule of Assessments Table 1 and in 
accordance with the Pharmacy Manual, the Investigator or designee will obtain the kit number from the 
IRT for the subject and the kit number will be provided to the blinded pharmacist or designee at the 
study center who is responsible for the preparation of study drug. The blinded pharmacist will then 
dispense the correct kit number to the subject.  
Each subject will receive 2 kits: the first for Days 1 to 7 and the second for Days 8 to 14. The kits 
numbers should be recorded in the eCRF and in the pharmacy dispensing logs. 
If an Investigator becomes unblinded to a given subject’s study treatment that subject will be 
discontinued from the study unless there are ethical reasons for that subject not to be discontinued; 
approval from the Sponsor’s medical monitor must be obtained in such instances. 
 
In the event that emergency unblinding is required for a given subject because of AEs or concerns for 
the subject’s safety or wellbeing, the Investigator may break the randomization code for the subject via 
the IRT, by which system the unblinding will be captured. The Investigator is responsible for notifying 
the medical monitor and/or Sponsor of such an event as soon as possible. The unblinding and its 
cause will also be documented in the eCRF. 
3.8. 
Administration of Study Medication 
The study treatments to be used in this study are:  
 
• 
2 mg SUVN-G3031  
• 
4 mg SUVN-G3031  
• 
Placebo  
 
Subjects should take 1 tablet per day in the morning, as soon as they wake up, with approximately 250 
mL water. Dosing may occur with or without food. Subjects will be dosed for 14 days.  


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If a subject forgets to take their morning dose and remembers before 1:00 PM, then they should take it 
as soon as they remember. If a subject forgets to take their morning dose and remembers after 1:00 
PM, then they should skip the day’s dose and take the next scheduled dose the next morning. If the 
subject has missed more than 1 dose, then they should only take the most recent forgotten dose. 
3.9. 
Study Procedures 
Subjects will be enrolled at approximately 65 sites in the United States and Canada. Each subject will 
receive study drug once daily, in a tablet formulation, for 14 days. It is anticipated it will take 12 months 
to complete enrollment and 13 months to complete the entire study. 
Table 1: Schedule of Assessments 
Visit 
Screening 
Visit 1 
Visit 2 
Visit 3 
Safety 
Follow-up 
Study Day 
Day -28 to 
Day -1 
Baseline 
(Day 0) 
Day 7 
Day 14 
Day 21 
Window 
 
 
±1 day 
±1 day 
±1 day 
Informed consent 
X 
 
 
 
 
Demographic information 
X 
 
 
 
 
Medical History and Disease 
History 
X 
 
 
 
 
Virology/Serologya 
X 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
Physical examination 
X 
X 
 
X 
X 
Vital signsb 
X 
X 
X 
X 
X 
ECG 
X 
Xc 
Xc 
Xc 
X 
Hematologyd 
X 
X 
 
X 
X 
Serum chemistryd 
X 
X 
 
X 
X 
Pharmacokinetic samplee 
 
X 
X 
X 
 
Urinalysisd 
X 
X 
 
X 
X 
Pregnancy testf 
X 
X 
X 
X 
X 
UDSg 
X 
X 
X 
X 
 
Nocturnal overnight PSGh 
 
X 
X 
X 
 
MWTi 
 
X 
X 
X 
 
CGI-Sj 
 
X 
X 
X 
 
CGI-Cj 
 
 
X 
X 
 
ESSk 
X 
X 
X 
X 
 
C-SSRSk 
X 
X 
X 
X 
X 
PGI-Ck,l 
 
X 
X 
X 
 
Diary dispensingm 
X 
X 
X 
X 
 
Washout from EDS/cataplexy 
medicationsn 
X 
 
 
 
 
Assign/randomize to IP 
 
X 
 
 
 


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Visit 
Screening 
Visit 1 
Visit 2 
Visit 3 
Safety 
Follow-up 
Study Day 
Day -28 to 
Day -1 
Baseline 
(Day 0) 
Day 7 
Day 14 
Day 21 
Window 
 
 
±1 day 
±1 day 
±1 day 
Dispense IP 
 
X 
X 
 
 
Collect IPo 
 
 
X 
X 
 
IP accountabilityo 
 
 
X 
X 
 
Prior medications/concomitant 
medicationso,p 
X 
X 
X 
X 
X 
AEs including AESIso,p 
X 
X 
X 
X 
X 
 
Abbreviations: AE, adverse event; AESI, adverse event of special interest; CGI-C, Change in Clinical Global Impression 
of Change; CGI-S, Clinical Global Impression of Severity; C-SSRS, Columbia Suicide Severity Rating Scale; ECG, 
electrocardiogram; ESS, Epworth Sleepiness Scale; IP, investigational product; MWT, Maintenance of Wakefulness 
Test; PGI-C, Patient Global Impression – Change; UDS, Urine Drug Screen. 
a 
Virology and Serology laboratory tests (i.e., Hepatitis B, Hepatitis C, and human immunodeficiency virus) will be 
completed at Screening. 
b 
Vital signs (i.e., SBP, DBP, body temperature, pulse, and respiratory rate) to be obtained after subject has been 
sitting for at least 5 min. The method of obtaining body temperature will be per sites standard practice but should be 
obtained by the same method for a given subject throughout the study. Vital signs may be collected prior to the PSG 
and the first MWT. 
c 
Electrocardiograms should be obtained after the subject has been quiet and supine for approximately 3 minutes. An 
ECG will be captured at baseline (Day 0, Visit 1), and 3 h (±30 min) post dose on Days 7 and 14. 
d 
Laboratory assessments are listed in protocol Table 2. 
e 
Venipuncture for point estimates of the plasma concentration of SUVN-G3031 will be obtained at baseline (Day 0; 
blank), and on Day 7 (Visit 2) and Day 14 (Visit 3) at the estimated trough just prior to dosing and at the estimated 
maximum plasma concentration of SUVN-G3031 (3 ± 0.5 hours post dosing on Day 7 and Day 14) for a total of 5 
samples. 
f 
A serum pregnancy test will be completed at baseline (Day 0; Visit 1). Urine pregnancy tests will be completed at 
Screening, Baseline (Visit 1), Day 7 (Visit 2), Day 14 (Visit 3), and Day 21 (Safety Follow-up visit). 
g  A positive UDS at Screening can be repeated up to Day -1; however, a negative UDS is required prior to Day 0 
(Baseline visit), and a second negative UDS is required on Day 0 (Baseline visit). 
h 
Within the current study nocturnal overnight PSG will be completed at baseline (Day 0; Visit 1), Day 7 (Visit 2), and at 
Day 14 (Visit 3). Variables to be collected will include latency to persistent sleep in minutes (latency from lights-off to 
the first epoch of 20 consecutive epochs of any stage of sleep), number of arousals, number of awakenings, sleep 
efficiency, total sleep time in minutes, wake after sleep onset in minutes, percentage of time in stage 1, 2, 3, 4, REM 
sleep percentage, REM sleep latency in minutes and periodically movements during sleep (N). 
i 
The 
 MWT will be utilized within this study and will be performed after a nocturnal overnight PSG at 
baseline (Day 0), Day 7, and at Day 14 according to validated standards. The MWT will begin at approximately 2 
hours after awakening (4 total MWT sessions will be performed at 2 hour intervals). Subjects will be required to 
recline in a quiet, dimly lit bedroom and instructed to remain awake for as long as possible. Each MWT session will 
be stopped after the onset of sleep or after 
 if sleep did not occur. The onset of sleep will be evaluated 
using a standard PSG montage and defined as 3 consecutive 30-second epochs of stage 1 sleep or 30 seconds of 
sleep stage 2, 3, 4, or rapid eye movement sleep. 
j 
 Physicians will complete a CGI-S and CGI-C assessments for EDS rather than totally of illness. The CGI-S 
assessment will be completed first followed by CGI-C evaluation. The administrator of the CGI-S and CGI-C should 
remain consistent for each subject at each visit. 
k 
ESS, PGI-C, C-SSRS assessments will be completed in this order at the beginning of each evaluation day prior to 
start of first MWT session. Note: 2 distinct forms of C-SSRS will be used: “Baseline-Screening” form will be used at 
Screening and “Since Last Visit” form will be used at subsequent visits. 


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l 
For the PGI-C, the subject will be asked to address the totality of experience on study medication, without attempts to 
demarcate between excessive daytime somnolence versus cataplexy. 
m Sleep diary is collected nightly by the subject from Screening through Visit 3. The subject will provide the sleep diary 
from the preceding week at the beginning of each visit. In addition, dosing data will be collected in the diary. 
n 
Washout period will occur within a maximum 28-day Screening period to allow for minimum drug free period of ≥ 7 
days for all stimulants targeting EDS, and ≥ 14 days for all agents targeting cataplexy prior to randomization and 
baseline (Day 0) assessments. 
o 
At the start of each visit as indicated, the subject will return IP that has not been used, provide sleep diary, report any 
modification in concomitant medication dosage or regimen, and research personnel will complete a nondirected 
inquiry for the detection of AEs. Safety assessments completed by the Investigator precede the efficacy 
assessments. 
p 
Concomitant medications and AEs may be collected prior to the PSG and the first MWT. 
 


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4. 
Study Endpoints 
4.1. 
Primary Efficacy Endpoint 
• 
Primary endpoint: Change from baseline in the mean total ESS score at Day 14 
4.2. 
Secondary Efficacy Endpoints 
• 
Change from baseline in the mean CGI-S score related to EDS at Day 14  
• 
Change from baseline in the mean MWT score at Day 14 
4.3. 
Exploratory Endpoints 
• 
Change from baseline in the mean total ESS score at Day 7 
• 
Change in MWT score, within each of the 4 MWT sessions within a single day (Day 7 and Day 
14) 
• 
Proportion of subjects reporting CGI-C scores of 1 or 2 at Day 7 and Day 14 (EDS) 
• 
Proportion of subjects reporting CGI-C scores of 1 or 2 or 3 at Day 7 and Day 14 (EDS) 
• 
Proportion of subjects reporting CGI-S scores related to EDS of 1 or 2 at Day 7 and Day 14 
• 
Proportion of subjects reporting CGI-S scores related to EDS of 1 or 2 or 3 at Day 7 and Day 14 
• 
Proportion of subjects with improvement in the PGI-C score from baseline to Day 7 and Day 14 
• 
Change from baseline in the behavior of Sleep Diary parameters at Day 7 and Day 14 (7-day 
average) 
• 
Change from baseline in the mean CGI-S score related to EDS at Day 7 
• 
Changes in the behavior of the nocturnal overnight PSG assessments at Day 7 and Day 14 
• 
Change from baseline in the mean MWT score at Day 7 
• 
Analysis of all endpoints (except Sleep Diary parameters and nocturnal overnight PSG 
assessments) evaluating SUVN-G3031 doses (2 mg and 4 mg) compared to placebo. 
4.4. 
Pharmacokinetic Endpoints 
Not applicable for this study.  
The plasma concentration data will be summarized using descriptive statistics and all plasma 
concentration data will be listed using the PK population. 
4.5. 
Pharmacodynamic Endpoints 
No Pharmacodynamic assessments performed for this study. 
4.6. 
Safety Endpoints 
• 
Physical examination 
• 
Vital signs 
• 
Laboratory assessments (blood and urine) 
• 
Electrocardiogram (ECG) 
• 
Adverse events (AEs) 
• 
Adverse events of Special Interest (AESIs) 
• 
Columbia-Suicide Severity Rating Scale (C-SSRS) 


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4.7. 
Health-economics Endpoints 
Not applicable for this study. 
4.8. 
Other Endpoints 
Not applicable for this study. 


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5. 
Analysis Population 
5.1. 
Safety Population 
The safety population will include all randomized subjects who receive at least 1 dose of study 
treatment. The treatment group assignment in this population will be defined by the treatment actually 
received. This population will be used for the analysis of safety.  
5.2. 
ITT Population 
The intent-to-treat (ITT) population will include all subjects who were randomized, received at least 
one dose of study treatment drug, and had baseline and at least one post-baseline primary efficacy 
assessment. This population will be used for the analysis of efficacy.  
5.3. 
Per Protocol (PP) Population 
The Per Protocol (PP) population will be a subset of ITT population consisting of those subjects who 
complete 14 days treatment and had no major protocol deviation affecting the primary efficacy 
variable. All protocol deviations will be assessed and documented on a case-by-case basis before the 
database lock, and deviations considered to have a serious impact on the efficacy results will lead to 
the relevant subject being excluded from the PP population. Before database lock, potential subject 
exclusions from PP population will be reviewed by the Sponsor and documented in a subject 
evaluability document. 
5.4. 
Pharmacokinetic (PK) Population 
The PK population will include all subjects who receive at least 1 dose of study treatment with 
sufficient post dose plasma concentration data. This population will be used for PK analysis, 
summaries will be provided by actual treatment received.  
5.5. 
Pharmacodynamic Population 
Not applicable for this study. 
5.6. 
Other Analysis Population 
Not applicable for this study. 
5.7. 
Protocol Deviations 
All subjects protocol deviations will be summarized with number and percentage by treatment group: 
Protocol deviations data will be summarized on all randomized subjects. 
A listing will be produced containing the following information: 
o 
Date 
o 
Minor or Major deviation 
o 
Category of deviation 
o 
Description of deviation 
 
The listing will be presented for the all randomized subjects. 


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6. 
General Aspects for Statistical Analysis 
6.1. 
General Methods 
The statistical evaluation will be performed using SAS® software version 9.4 or higher (SAS Institute, 
Cary, NC). All data will be listed, and summary tables and figures will be provided.  
• 
Summary tables will be organized by treatment group. Descriptive statistics for continuous 
variables will include number of subjects (n), mean, standard deviation, median, minimum, 
and maximum, unless otherwise noted. Frequency and percentage will be calculated for 
categorical variables. Unless stated otherwise, all summary tables will present descriptive 
statistics and/or frequencies by treatment.  
• 
All data listings will be sorted by treatment and subject number. Data listing will be provided 
for all randomized subjects with exception of few listings which will be provided for all 
enrolled subjects. 
• 
Unscheduled assessments will not be included in summary tables unless specified otherwise 
but will be included in the subject listings. 
6.2. 
Key Definitions 
6.2.1. Baseline  
In general, the last non-missing valid observation before first dose of study drug will serve as the 
baseline measurement.  
6.2.2. Body Mass Index 
The BMI of a subject will be calculated in kg/m² as BMI = body weight [kg] / (height [m])². 
6.2.3. Change from Baseline 
Change = Post-baseline value – Value at baseline. 
Relative change = [(Post-baseline value – Value at baseline)/ Value at baseline] x100. 
6.2.4. Treatment Accountability and Compliance 
The pharmacist or other designated individual will maintain records of study treatment delivered to 
the study site, the inventory at the study site, the distribution to and use by each subject and the 
return of any required materials to the Sponsor. Study sites will be responsible for disposal of study 
treatment. Records should include dates, quantities, batch/serial numbers, expiration dates, in-clinic 
temperature log, and unique code numbers assigned to the product and study subjects. 
At each visit after initiation of treatment, study site personnel will record compliance of the subject 
with the subject’s assigned regimen. Subjects will be instructed to bring their sleep diaries and 
unused/partially used/empty bottles back for inspection at each study visit. Subjects are to be 
reminded of the importance of compliance with their assigned regimen, with an emphasis on taking 
their study drug on schedule and maintaining the prescribed interval between doses. 


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Subjects with missing sleep diaries or with missing entries in sleep diaries for dosing will be 
considered as treated if number of tablets returned at post baseline visit are less than the number of 
tablets dispensed at baseline visit. 
Investigators will maintain records that adequately document that the subjects were provided with the 
correct study treatment kits and reconcile the products received from the drug dispensing center. 
Investigational product will not be disposed until accountability has been fully monitored. 
Medication containers must be returned at each visit, as compliance will be assessed by tablet 
counts. Noncompliance is defined as taking less than <80% or more than 120% of study drug during 
any outpatient evaluation period (visit to visit). Discontinuation for noncompliance is at the 
Investigator’s discretion and is to be noted on the eCRF. 
Compliance until Day 7 visit, Compliance between Day 7 and Day 14 visit and Overall Treatment 
Compliance will be present in continuous summary (Number, Mean (SD), Median and Min, Max) 
 
Categorized Overall Compliance [n (%)] 
• 
< 80% 
• 
80% - 120% 
• 
>120% 
 
6.2.5. Days of Study Termination 
Days of study termination = End of study date – Randomization date + 1. 
6.2.6. Study Completion 
A subject will be defined as “completed” if she/he remained in the study up to End of study (see End 
of study CRF). Termination at a time point and prior to this will be considered as discontinuation. 
6.2.7. Duration of AE 
Duration of AE [days] = Date of stop of AE – Date of start of AE + 1. 
6.2.8. Prior/Concomitant Medication 
A medication is regarded as ‘prior’ if the stop date of the event is prior to the first dose of study drug, 
irrespective of the start date. 
A medication is regarded as ‘concomitant’ if it is not ‘prior’ and the start date or stop date is between 
the date of first dose of study drug (included) and the End of study date (included). 
A medication is regarded as ‘concomitant’ if ticked as ongoing on the CRF. 
 
6.2.9. Study Day 1 
Study day 1 will be the first day of study drug administration. 
First day of study drug administration is defined as first dispensation date + 1. 


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6.3. 
Missing Data 
6.3.1. Missing Dates 
No missing date will be imputed. 
6.3.2. Missing values 
Efficacy - Missing Values at Baseline: If a value is missing at baseline but there are non-missing 
post-baseline values, the missing baseline will be imputed as the first post-baseline non-missing 
assessment of the subject. 
6.4. 
Visit Windows 
All assessments will be included in the listings. No visit windows will be applied to assessments. 
6.5. 
Pooling of Centers 
Data from all centers/sites will be pooled together. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  






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8. 
Efficacy Evaluation 
The primary testing approach for efficacy is the statistical comparison of the pooled active SUVN-G3031 
dose groups (2 mg/day and 4 mg/day) versus placebo. Additionally, each active dose will be tested against 
placebo. All statistical tests will be performed at alpha=5% for the two-sided test. 
8.1. Primary Efficacy Endpoint and Analysis (Primary Estimand) 
The null (H0) and alternative (H1) hypotheses of the study are as follows:  
H0: SUVN-G3031 and placebo do not differ in their change from baseline in the mean total ESS 
score at Day 14. 
H1: SUVN-G3031 and placebo differ in their change from baseline in the mean total ESS score at 
Day 14. 
The primary estimand is defined with the following 5 attributes: 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
The primary analysis approach will be performed using a mixed model repeated measures (MMRM) 
analysis. This model considers all observed post-baseline assessments of both post-baseline visits 
(Day 7 and Day 14), in case of death, the visits after the death will be filled with the worst observed 
value post-baseline, prior to entering the MMRM. In the MMRM all missing values will be imputed via 
direct likelihood based on the assumption of missing at random. 
The MMRM model will include randomized treatment (for the pooled analysis, both active treatments 
will be combined), visit and treatment (for the pooled analysis, both active treatments will be 
combined) by visit interaction as explanatory variables, stratification factor for cataplexy subject 
history (presence or absence) and baseline MWT score as continuous covariates. An unstructured 
covariance structure will be assumed. Least square mean changes will be estimated for each single 
treatment and the difference of each SUVN-G3031 dose versus placebo. Results of comparison of 
pooled active treatment groups versus placebo will be presented. Additionally, the analysis will be 
repeated with consideration of single treatment groups. 


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If the assumptions underpinning the MMRM are found to be violated, either a log transform or an 
analysis based on ranked data will be performed as appropriate and least squares means, 95% 
confidence intervals, and p-values of the treatment comparisons (across visits and within visits) for 
descriptive purposes along with basic arithmetic summary statistics (mean, median, SD, standard 
error of the mean, min, and max) will be provided. 
If the statistical comparison of pooled active dose group versus placebo results in superiority with p-
values less or equal to 5% then SUVN-G3031 can be considered as superior to placebo in a 
confirmatory way. Otherwise result will be interpreted in an exploratory way.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8.4. 
Secondary Efficacy Endpoint(s) and Analyses (Secondary Estimands) 
The secondary efficacy endpoints for this study are: 
• 
Change from baseline in the mean CGI-S score related to EDS at Day 14  
• 
Change from baseline in the mean MWT score at Day 14 
The two secondary estimands investigate the efficacy endpoints ‘Difference to placebo in the change 
from baseline in the CGI-S score related to EDS at Day 14’ on the ITT population using a MMRM 
analysis, and the ‘Difference to placebo in the Change from baseline in the MWT score at Day 14’ on 
the ITT population using a MMRM analysis. MMRM considers all observed post-baseline 
assessments of both post-baseline visits (Day 7 and Day 14), , in case of death, the visits after the 
death will be filled with the worst observed value post-baseline from all subjects, prior to entering the 
MMRM In the MMRM all missing values will be imputed via direct likelihood based on the assumption 
of missing at random. 
The approaches to handle intercurrent events for secondary endpoints will be consistent with those 
for the primary endpoint. 
The testing of secondary endpoints will be controlled using hierarchical testing methods. The testing 
of the first secondary efficacy endpoint will be performed in a confirmatory way only, if for the primary 
efficacy of pooled treatment is significant versus placebo. The confirmatory testing approach will 
proceed to the second secondary efficacy endpoint only, if pooled active treatment comparison 
versus placebo is significant for the first secondary efficacy endpoint.Otherwise the results will be 
considered as exploratory only. 


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The secondary endpoints will be analyzed similar to the primary efficacy endpoint: using MMRM with 
multiple imputation and an ANCOVA of Day 7 and Day 14 data with multiple imputation as sensitivity 
analyses, and by repeating the analyses on PP as supportive analyses.  
The time course (Baseline, Day 7, Day 14) of mean values of CGI-S and MWT, respectively, together 
with +/- standard error of mean will be presented in figures for the ITT and PP populations. 
Summary tables by visit by treatment with actual and changes from baseline (if applicable) will be 
provided for the ITT and PP population. 
8.5. 
Analysis of Exploratory Endpoints 
Summary tables with actual and changes from baseline (if applicable) will be provided for the 
continuous exploratory endpoints (listed below), and they will be analyzed in a similar fashion as the 
primary endpoint, i.e., an MMRM using the ITT population and PP population. No imputations will be 
applied in the analysis of exploratory endpoints except total ESS score at Day 7, CGI-S score at Day 
7 and MWT score at Day 7. 
• Change from baseline in the mean total ESS score at Day 7 
• Change from baseline in the mean CGI-S score related to EDS at Day 7 
• Change from baseline in the mean MWT score at Day 7 
• Change from baseline in the behavior of Sleep Diary parameters at Day 7 and Day 14 (7-day 
average) 
• Changes in the behavior of the nocturnal overnight PSG assessments at Day 7 and Day 14 
• Change in MWT score, within each of the 4 MWT sessions within a single day (Day 7 and Day 14) 
Frequency tables will be provided. For binary assessments (listed below), a repeated measures 
responder analyses will use a generalized estimating equations with a logit link function and starting 
with an unstructured working correlation matrix. No imputations will be applied in the analysis of 
below endpoints. 
• The proportion of subjects reporting CGI-C scores of 1 or 2 at Day 7 and Day 14 (EDS) 
• Proportion of subjects reporting CGI-C scores of 1 or 2 or 3 at Day 7 and Day 14 (EDS) 
• The proportion of subjects reporting CGI-S scores related to EDS of 1 or 2 at Day 7 and Day 14 
• Proportion of subjects reporting CGI-S scores related to EDS of 1 or 2 or 3 at Day 7 and Day 14 
• Proportion of subjects with improvement in the PGI-C score from baseline to Day 7 and Day 14 
• Analysis of all endpoints (except Sleep Diary parameters and nocturnal overnight PSG 
assessments) evaluating SUVN-G3031 2 mg or 4 mg compared with placebo. 
Factors included in the model will be treatment group, a stratification factor for cataplexy subject 
history, visit, treatment-by-visit interaction, and baseline value as a covariate. Model estimates will be 
based on Wald statistics. 


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Sleep diary and measures collected as part of the nocturnal overnight PSG assessments at Day 7 
and Day 14 will be summarized using descriptive statistics. 
Further exploratory analyses will include each individual MWT session throughout the day in 
comparison to matched baseline sessions (morning, afternoon, or evening testing periods as defined 
within the protocol). 


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9. 
Analysis of Pharmacokinetics 
Individual SUVN-G3031 plasma concentrations versus time at pre-dose on baseline (day 0), at pre-
dose and post dose (3 ± 0.5 h) on day 7 day 14 will be summarized versus time points of collection 
and by treatment dose using descriptive statistics of the PK profile. 
The following descriptive statistics (number of subjects, arithmetic and geometric mean, SD, % 
coefficient of variation, % Geometric coefficient of variation, minimum, maximum, and median) of the 
plasma concentrations versus time will also be presented on PK population.  
The concentration data will also be listed by time points of collection. 
 
Figures:  
Summarized (Mean ± SD, N) SUVN-G3031 plasma concentrations versus time at pre-dose on 
baseline (day 0), at pre-dose and post dose (3 ± 0.5 h) on day 7 and day 14 by treatment will be 
presented on a linear scale. 
Summarized (Mean ± SD, N) SUVN-G3031 plasma concentrations versus time at pre-dose on 
baseline (day 0), at pre-dose and post dose (3 ± 0.5 h) on day 7 and day 14 by treatment will be 
presented on a log scale. 
 
 






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• 
any fatal AE 
• 
any AE leading to treatment discontinuation 
 
All TEAEs for each subject, including multiple occurrences of the same event, will be presented for all 
randomized subjects. In a separate listing all non-TEAEs of randomized subjects will be provided. 
10.4. Laboratory Evaluations 
Descriptive statistics will be performed for those laboratory parameters on a continuous scale for 
actual values and change from baseline at each visit, by treatment. Categorical results for urinalysis 
will be summarized using frequency tabulations. Abnormal values for each analyte will be determined 
using reference ranges provided by the central laboratory. All laboratory results will be listed including 
unscheduled visits. Additionally, shift table of post-baseline to baseline of the values below normal 
range, within normal range and above normal range will be provided. 
Dipstick urinalysis results evaluation (Normal, Abnormal Not Clinically Significant and Abnormal 
Clinically Significant) will be summarized at each protocol scheduled time point by treatment group 
using frequency tabulations. All abnormal laboratory values will be flagged in the listings. 
The following table summarizes all laboratory parameters which will be assessed in the study. 
Hematology 
Serum Chemistry 
Urine Analysis (Dipstick) 
Hematocrit 
Hemoglobin 
Red blood cell count 
White blood cell count with 
differential 
Platelets 
Red blood cell indices 
Albumin 
Alanine aminotransferase 
Alkaline phosphatase 
Aspartate aminotransferase 
Blood urea nitrogen or urea 
Creatinine 
Electrolytes (sodium, 
potassium, chloride, calcium) 
Gamma glutamyltransferase 
Glucose 
Lactate dehydrogenase 
Total bilirubin 
Direct bilirubin 
Uric acid 
Follicle-stimulating hormonea 
Thyroid stimulating hormoneb 
Appearance 
pH 
Protein 
Glucose 
Ketone bodies 
Indicators of blood and white blood 
cells 
Specific gravity 
Urobilinogen 
Microscopic analysis will occur 
when dipstick indicates clinically 
significant changes in one of the 
above. 
Virology/Serology tests: Virology and Serology laboratory tests (i.e., Hepatitis B, Hepatitis C, and 
human immunodeficiency virus) will be completed at Screening. 
Pregnancy test: A pregnancy test will be performed on all women of childbearing potential at 
Screening, baseline, Day 7, Day 14, and follow-up. Additionally, a serum pregnancy test will also 
be performed at baseline. 
Urine drug screen: The following drugs will be tested for: barbiturates, benzodiazepines, cocaine, 
cannabinoids, methadone, methamphetamines, morphine/opiates, phencyclidine, and tricyclic 
antidepressants. 
a 
Serum follicle-stimulating hormone tests will be completed as necessary. 
b Thyroid stimulating hormone tests will be completed at Investigator’s discretion. 


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Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening, 
Baseline, and follow-up. After administration of study drug, any known cases of pregnancy in female 
subjects or female partners of male subjects will be reported until the subject completes or withdraws 
from the study.  
A listing with pregnancy test results will be summarized for all randomized female subjects. 
10.5. Vital Signs 
Vital signs (body temperature, respiration rate, heart rate, and systolic and diastolic blood pressure 
measurements) will be evaluated at the visits indicated in the Schedule of Assessments. All vital 
signs will be measured after the subject has been resting in a sitting position for at least 5 minutes. 
Blood pressure measurements are to be taken in the same arm for the duration of the study. Body 
weight (without shoes) will be recorded whenever vital signs are recorded; height (without shoes) will 
be recorded at Screening only. 
Vital signs and body weight will be summarised at each protocol scheduled time point by treatment 
group. Actual values and changes from baseline will be presented. Vital signs and body weight will be 
listed for all randomized subjects. 
10.6. Electrocardiogram (ECG) 
A frequency tabulation of ECG results evaluation (Normal, Abnormal Not Clinically Significant or 
Abnormal Clinically Significant) will be presented at each protocol scheduled time point, by treatment 
group at each time point. Additionally, a shift table of the overall ECG evaluation at the post-baseline 
visits compared to baseline will be provided. 
10.7. Physical Examination 
Physical examination data (Normal/Abnormal) at each visit will be listed by body system for all 
randomized subjects. 
10.8. Columbia-Suicide Severity Rating Scale (C-SSRS) 
Two versions of the C-SSRS are to be used in the study: The first is to be used at Screening and will 
assess lifetime suicidal ideation and behavior until that point (Baseline-Screening Form). Identification 
of active suicidal ideation will exclude the subject from enrollment in the study. At each subsequent 
visit, the follow-up C-SSRS is used (Since Last Visit form) to assess suicidal ideation and behavior 
since the last visit. 
The C-SSRS data, i.e. suicidal ideation severity, suicidal ideation intensity, suicidal behavior, non-
suicidal self-injuries behavior and lethality, will be summarized by treatment arm and visit for the 
Safety Population. Additionally, a frequency table of subjects answering Yes to questions of C-SSRS 
form by any question will be provided by treatment arm for the Safety Analysis Set. A listing of all 
randomized subjects will be provided. 
 
 
 
 


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11.2. Brief Description of CHW 
The Cui, Hung, Wang (CHW; Cui, Hung et al. 1999) weighted test statistic to analyze the primary and 
secondary efficacy endpoint (i.e., for total ESS and mean MWT) at the end of the study is described 
below and it preserves the type 1 error in case of updated sample size: 
Cui-Hung-Wang (CHW) approach defines a weighted statistic (Z), data from the 2-stages (stage 1 
uses all data until interim analysis, stage 2 uses all data after interim analysis) by weighting the stage 
wise Wald test statistics 
 
 
 
The CHW pooled test statistic combines the two stages statistics together and applies the weighting, 
 
Confidence interval and point estimate: 
A 100(1-α)% Confidence Interval; 
 
Point Estimate, 
 ; 
 


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Where W1 is time measured on information scale and will be around 50%, W* is time measured after 
doing possible adjustment to initial maximum information (W*>W1). Please note, Time is measured on 
the information scale and is rescaled so that the study as originally planned will have maximum 
information equal to one. K-1 = S*sqrt((1/n1)+(1/n2)), is constant and depends on initial maximum 
information, where S is square root of poolled variance. 
Deriving a point estimate and confidence interval will be aligned with the CHW test statistic (Lawrence 
& Hung, 2003). These point estimates will be used for MWT and ESS. 
 
 
11.3. Conditional Power 
The conditional power (CP) at the IA is calculated assuming that the estimated treatment difference is 
the true effect. Thus, CP can be obtained with (Mehta & Pocock, 2011): 
 
 
Where: 
• 
n1 represents the number of subjects needed to perform the interim analysis, n2 the number of 
subjects needed to perform the final analysis, and ñ2 represents the increment of subjects 
between the IA and the final analysis (i.e., n2=n1+ñ2). 
• 
z is the test statistic calculated from the observed data up to the interim analysis (z1) or under a 
significance level of alpha. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  


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13. 
Reference List 
1) For 
missing 
data 
assumptions 
refer 
to 
the 
ICH 
E9(R1) 
draft 
guidance 
on 
https://www.fda.gov/media/108698/download. 
2) Lu Cui, H. M. James Hung,' and Sue-Jane Wang (1999): Modification of Sample Size in Group 
Sequential Clinical Trials. BIOMETRICS 55, 853-857. 
3) Cyrus R. Mehta, and Stuart J. Pocock (2011): Adaptive increase in sample size when interim results 
are promising: a practical guide with examples. Stat Med 30(28): 3267-3284. 
4) Ping Gao, James H. Ware, Cyrus Mehta (2008): Sample size re-estimation for adaptive sequential 
design in clinical trials. Journal of Biopharmaceutical Statistics, 18: 1184–1196. 
5) W. Joseph Herring, Kenneth Liu, Jill Hutzelmann, Duane Snavely, Ellen Snyder, Paulette Ceesay, 
Christopher Lines, David Michelson, Thomas Roth(2013): Alertness and psychomotor performance 
effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on 
continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized 
adaptive crossover study, Sleep Medicine 14 (2013) 955–963. 
6) Terri E. Weaver, Susan D. Mathias, Ross D. Crosby, Morgan Bron, Shay Bujanover, Diane Menno, 
Kathleen F. Villa, Christopher Drake (2020): Relationship between sleep efficacy endpoints and 
measures of functional status and health-related quality of life in participants with narcolepsy or 
obstructive sleep apnea treated for excessive daytime sleepiness, J. Sleep Res.. 2020;00:e13210. 
7) Lawrence, J. and Hung, H.J. (2003), Estimation and Confidence Intervals after Adjusting the 
Maximum Information. Biom. J., 45: 143‐152.  
8) van der Heide A, van Schie MK, Lammers GJ, Dauvilliers Y, Arnulf I, Mayer G, Bassetti CL, Ding CL, 
Lehert P, van Dijk JG. Comparing Treatment Effect Measurements in Narcolepsy: The Sustained 
Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test. 
Sleep. 2015;38(7):1051-8. 
9) Inoue, Y., Uchiyama, M., Umeuchi, H., Onishi, K., Ogo, H., Kitajima, I., Matsushita, I., Nishino, I., & 
Uchimura, N. (2022). Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: 
two randomized, double-blind, placebo-controlled trials. BMC psychiatry, 22(1), 141. 
 


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14. 
Programming Considerations 
 
All statistical computations and construction of tables, listings and figures will be performed using 
SAS® for Windows Version 9.4 or higher (SAS® Institute Inc., Cary, NC, USA). Pharmacokinetic 
calculations will be performed using PheonixTM WinNonlin® (Version 8.0 or higher, Pharsight 
Corporation) and/or SAS® (Version 9.4 or higher, SAS® Institute Inc.). 
The format of the table shells will be followed as closely as possible; however, in the course of 
programming and familiarization with the database, some changes may become necessary. All 
changes will be documented. Major changes will be documented through a formal amendment to this 
document. 
SDTM datasets will be created from the clinical database and external data, following the Study Data 
Tabulation Model Implementation Guide Version 3.2 or latest version. Analysis will be based on 
ADaM datasets created from the SDTM datasets. 
The below programming considerations will be followed unless already specified in the above text. 
14.1. General Considerations 
• 
One SAS program may create several outputs. 
• 
Each output will be stored in a separate file. 
• 
Output files will be delivered in Word format. 
• 
Numbering of TFLs will follow International Conference on Harmonisation (ICH) E3 guidance 
 
14.2. Table, Listing, and Figure Format 
14.3. General 
• 
All TFLs will be produced in landscape format, unless otherwise specified.  
• 
All TFLs will be produced using the Courier New font, size 8. 
• 
The data displays for all TFLs will have a minimum blank 1-inch margin on all 4 sides. 
• 
Headers and footers for figures will be in Courier New font, size 8.  
• 
Legends will be used for all figures with more than 1 variable, group, or item displayed. 
• 
TFLs will be in black and white (no color), unless otherwise specified. Colors may be used in 
figures. 
• 
Specialized text styles, such as bolding, italics, borders, shading, and superscripted and 
subscripted text, will not be used in the TFLs, unless otherwise specified. On some 
occasions, superscripts 1, 2, or 3 may be used (see below). 
• 
Only standard keyboard characters will be used in the TFLs. Special characters, such as 
non-printable control characters, printer-specific, or font-specific characters, will not be used. 
Hexadecimal-derived characters will be used, where possible, if they are appropriate to help 
display math symbols (e.g., μ). Certain subscripts and superscripts (e.g., cm2, Cmax) will be 
employed on a case-by-case basis. 
• 
Mixed case will be used for all titles, footnotes, column headers, and programmer-supplied 
formats, as appropriate. 
14.3.1. Headers 
• 
All outputs should have the following header at the top left of each page: 
 


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Suven Life Sciences 
 
Protocol No: CTP2S13031H3 
 
Draft/Final Run 
 
• 
All outputs should have “Page n of N” at the top or bottom right corner of each page. TFLs 
are internally paginated in relation to the total length (i.e., the page number should appear 
sequentially as page n of N, where N is the total number of pages in the table). 
• 
The date output was generated should appear along with the program name as a footer on 
each page. 
14.3.2. Display Titles 
• 
Each TFL will be identified by the designation and a numeral. (i.e., Table 14.1.1). ICH E3 
numbering will be followed. A decimal system (x.y and x.y.z) is used to identify TFLs with 
related contents. The title is centered. The analysis Population is identified on the line 
immediately following the title. The title and table designation are single spaced. A solid line 
spanning the margins will separate the display titles from the column headers. There will be 
1 blank line between the last title and the solid line. 
 
Table x.y.z 
First Line of Title 
Second Line of Title if Needed 
(Mock Shells specified Analysis Population) 
14.3.3. Column Headers 
• 
Column headings will be displayed immediately below the solid line described above in initial 
upper-case characters. 
• 
For numeric variables, include “unit” in column or row heading when appropriate. 
• 
Analysis Population sizes will be presented in the column heading as (N=xx) (or in the row 
headings, if applicable). This is distinct from the ‘n’ used for the descriptive statistics 
representing the number of subjects in the analysis Population. 
14.3.4. Body of the Data Display 
14.3.4.1. 
General Conventions 
 
  
Data in columns of a table or listing are formatted as follows: 
• 
Alphanumeric values are left-justified; 
• 
Whole numbers (e.g., counts) are right-justified; and 
• 
Numbers containing fractional portions are decimal aligned. 
14.3.4.2. 
Table Conventions 
• 
Units will be included where available. 
• 
If the categories of a parameter are ordered, then all categories between the minimum and 
maximum category are presented in the table, even if n=0 for in a given category that is 
between the minimum and maximum level for that parameter. For example, the frequency 
distribution for symptom severity would appear as: 
 
 


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Severity Rating 
N 
Mild 
3 
moderate 
8 
Severe 
0 
 
 
The same convention will be followed for data where categories are not ordered (e.g., Reasons 
for Discontinuation from the Study, etc.) i.e. all possible responses available on the CRF will be 
presented in the table even if there are one or more categories with n = 0 for all treatment 
groups. 
 
Where percentages are presented in these tables, zero percentages will not be presented and 
so counts of 0 will be presented as 0 and not as 0 (0%). 
• 
An Unknown or Missing category will be added to each parameter for which information is 
not available for 1 or more subjects.  
• 
Unless otherwise specified, the estimated mean and median for a set of values are printed 
out to 1 more significant digit than the original values, and standard deviations are printed 
out to 2 more significant digits than the original values. The minimum and maximum should 
report the same significant digits as the original values. For example, for systolic blood 
pressure: 
N 
XX 
Mean (SD) 
XXX.X (X.XX) 
Median 
XXX.X 
Min, Max 
XX, XXX 
 
• 
P-values are output in the format: “0.xxx”, where xxx is the value rounded to 3 decimal 
places. Any p-value less than 0.001 will be presented as <0.001. If the p-value is less than 
0.0001, then it will be presented as <0.0001. If the p-value is returned as >0.999, then it will 
be presented as >0.999. 
• 
Percentage values will be printed to one decimal place, in parentheses with no spaces, one 
space after the count (e.g., 7 (12.8%), 13 (5.4%)). Unless otherwise noted, for all 
percentages, the number of subjects in the analysis Population who have an observation will 
be the denominator. Percentages after zero counts should not be displayed and 
percentages equating to 100% are presented as 100%, without decimal places.  
• 
Tabular display of data for medical history, prior/concomitant medications, and all tabular 
displays of adverse event data will be presented by the body system or SOC with the 
highest occurrence in decreasing order, assuming all terms are coded. Within the body 
system, drug class and SOC, medical history (by preferred term), drugs (by ATC1 code), 
and adverse events (by preferred term) are displayed in decreasing order. If incidence for 
more than 1 term is identical, they should then be sorted alphabetically. Missing descriptive 
statistics or p-values which cannot be estimated will be reported as “-”. 
• 
For categorical summaries (number and percentage of subjects) where a subject can be 
included in more than one category, a footnote or programming note will be used to explain 


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if the subject is included in the summary statistics for all relevant categories or just 1 
category and the criteria for selecting the criteria. 
• 
Where a category with a subheading (such as system organ class) has to be split over more 
than one page, the subheading followed by “(cont)” will be printed at the top of each 
subsequent page.  The overall summary statistics for the subheading will only be displayed 
on the first relevant page. 
14.3.4.3. 
Listing Conventions 
• 
Listings will be sorted for presentation in order of subject number, visit/collection day, and 
visit/collection time. 
• 
Missing data will be represented on listings as either a hyphen (“-”) with a corresponding 
footnote (“- = unknown or not evaluated”), or as “N/A”, with the footnote “N/A = not 
applicable”, whichever is appropriate. 
• 
Dates will be printed in SAS DATE9.format (“ddMMMyyyy”: 01JUL2000). Missing portions of 
dates will be represented on data listings as dashes (--JUL2000). Dates that are missing 
because they are not applicable for the subject will be output as “N/A”, unless otherwise 
specified. 
• 
All observed time values are to be presented using a 24-hour clock HH:MM:SS or HH:MM 
format (e.g., 11:26:45, or 11:26). Time will only be reported if it was measured as part of the 
study. 
• 
Units will be included wherever available 
14.3.4.4. 
Figure Conventions 
• 
Unless otherwise specified, for all figures, study visits will be displayed on the X-axis and 
endpoint (e.g., treatment mean change from Baseline) values will be displayed on the Y-
axis. 
14.3.4.5. 
Footnotes 
• 
A solid line spanning the margins will separate the body of the data display from the 
footnotes.  
• 
All footnotes will be left justified with single-line spacing immediately below the solid line 
underneath the data display. 
• 
Footnotes should always begin with “Note:” if an informational footnote, or 1, 2, 3, etc. if a 
reference footnote. Each new footnote should start on a new line, where possible. 
• 
Subject specific footnotes will be avoided, wherever possible. 
• 
Footnotes will be used sparingly and add value to the table, figure, or listing. If more than six 
lines of footnotes are planned, then a cover page will be used to display footnotes, and only 
those essential to comprehension of the data will be repeated on each page.  


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• 
The last line of the footnote section will be a standard source line that indicates the name of 
the program used to produce the data display and the date the program was run (i.e., 
‘Program: myprogram.sas Date generated: ddMMMyyyy). 


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15. 
Quality Control 
 
SAS programs are developed to produce output such as analysis data sets, summary tables, data 
listings, figures or statistical analyses. An overview of the development of programs is detailed in 
 SOP Developing Statistical Programs 
 
 
 SOPs Developing Statistical Programs 
 and Conducting the Transfer of Bio 
statistical Deliverables 
describes the quality control procedures that are performed for all SAS 
programs and output. Quality control is defined here as the operational techniques and activities 
undertaken to verify that the SAS programs produce the output by checking for their logic, efficiency 
and commenting and by review of the produced output.”   


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17. Index of Listings 
Mock Listings Titles 
 
 
1. 
Listing 16.2.1.7 Randomization Scheme and Treatment Assigned Randomized Subjects 
 
2. 
Listing 16.2.1.1 Subject Disposition Randomized Subjects 
 
3. 
Listing 16.2.1.2 Screening Failures Enrolled Subjects  
4. 
Listing 16.2.2 Protocol Deviations Randomized Subjects 
 
5. 
Listing 16.2.3 Exclusions from Populations Enrolled Subjects  
6. 
Listing 16.2.4.1 Demographic and Baseline Characteristics Randomized Subjects 
 
7. 
Listing 16.2.4.2.1 Medical History Randomized Subjects 
 
8. 
Listing 16.2.4.2.2 Disease History Randomized Subjects 
 
9. 
Listing 16.2.4.3 Prior and Concomitant Medications Randomized Subjects 
 
10. 
Listing 16.2.5.1 Study Drug Exposure Randomized Subjects  
11. 
Listing 16.2.5.2 Study Drug Accountability and Compliance Randomized Subjects 
 
12. 
Listing 16.2.5.3 Pharmacokinetic Blood Sample Collection Times and Concentration Data 
Randomized Subjects 
 
13. 
Listing 16.2.6.1 Epworth Sleepiness Scale (ESS) Randomized Subjects 
 
14. 
Listing 16.2.6.2 Clinical Global Impression of Severity (CGI-S) Related to EDS Randomized 
Subjects 
 
15. 
Listing 16.2.6.3 Maintenance of Wakefulness Test (MWT) Randomized Subjects 
 
16. 
Listing 16.2.6.4 Clinical Global Impression of Change (CGI-C) Related to EDS Randomized 
Subjects 
 
17. 
Listing 16.2.6.5 Patient Global Impression of Change (PGI-C) Related to EDS Randomized 
Subjects 
 
18. 
Listing 16.2.6.6 Sleep Diary Randomized Subjects 
 
19. 
Listing 16.2.6.7 Polysomnography (PSG) Test Randomized Subjects  
20. 
Listing 16.2.7.1 Treatment-Emergent Adverse Events Randomized Subjects  
21. 
Listing 16.2.7.2 Non-Treatment-Emergent Adverse Events Randomized Subjects 
 
22. 
Listing 16.2.8.1.1 Hematology Randomized Subjects  
23. 
Listing 16.2.8.1.2 Serum Chemistry Randomized Subjects 
 
24. 
Listing 16.2.8.1.3 Urinalysis Randomized Subjects 
 
25. 
Listing 16.2.8.1.4 Urine Pregnancy Test Randomized Subjects- Female Subgroup 
 
26. 
Listing 16.2.8.1.5 Urine Drug Screen Randomized Subjects 
 
27. 
Listing 16.2.8.1.6 Serology/Virology Screened Subjects 
 
28. 
Listing 16.2.8.2.1 Vital Signs Randomized Subjects 
 
29. 
Listing 16.2.8.2.2 Electrocardiogram (ECG) Randomized Subjects 
 
30. 
Listing 16.2.8.2.3 Physical Examination Randomized Subjects 


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31. 
Listing 16.2.8.2.4.1 Suicidal Ideation based on C-SSRS: Questions Randomized Subjects 
 
32. 
Listing 16.2.8.2.4.2 Subjects with Suicidal Ideation based on C-SSRS: Intensity of Ideation 
Randomized Subjects 
 
33. 
Listing 16.2.8.2.4.3 Suicidal Behavior based on C-SSRS Randomized Subjects 
 
34. 
Listing 16.2.8.2.4.4 Subjects with Suicidal Behavior based on C-SSRS: Lethality Randomized 
Subjects 
 
 


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18. Shells 
           Mock shells for tables, listings and figures will be created in a separate document as an attachment to 
the SAP which may be updated, revised and finalized separately from the SAP.  


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19. Appendices 
 
 
 
  
  
 
  
  
 
 
 
 
 
 
 
 
 
  
 
  
   
  
 
 
 
 
 
 
 
 
 
 
  
  
 
  
  
 
 
 
 
 
 


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Statistical Analysis Plan 
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