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
Phase: PHASE2
Conditions: Narcolepsy
Sponsor: Suven Life Sciences Limited

 
 
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 
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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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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.