Clinical trial NCT02806895
Conditions: Obstructive Sleep Apnea Excessive Sleepiness
Keywords: Driving
Sponsor: Jazz Pharmaceuticals
Start date: 2016-07-05; Completion date: 2019-05-28
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to obstructive sleep apnea.

Detailed description:

Arms: arm 1: Once daily dosing arm 2: 150 mg/day for first 3 days and 300 mg/day for next 4 days
Interventions: intervention 1: JZP-110 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
JZP-110
Jazz Pharmaceuticals
Clinical Trial Protocol: 15-004 Amendment 3 
Page 1 of 92
Clinical Trial Protocol: 15-004 
Study Title:
A Randomized, Double-Blind, Placebo-Controlled, Crossover On-
Road Driving Study Assessing the Effect of JZP-110 on Driving 
Performance in Subjects with Excessive Sleepiness Due to Obstructive 
Sleep Apnea 
Study Phase:
Phase 2
Product Name:
JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride]
EUDRACT 
Number:
2015-003930-28 
Indication:
Treatment of excessive sleepiness in adult patients with obstructive 
sleep apnea to increase the ability to stay awake throughout the day 
Investigators:
Single Center
Sponsor:
Jazz Pharmaceuticals
3180 Porter Drive 
Palo Alto, CA 94304 
Tel: (650) 496-3777 
Sponsor’s 
Medical Director: 
Sponsor’s 
Medical Monitor: 
Original Protocol:
11 November 2015
Amendment 1:
18 March 2016
Amendment 2:
19 April 2016
Amendment 3:
28 April 2016
Confidentiality Statement
The information in this document is Jazz Pharmaceuticals confidential information. This 
material may be used only for evaluating or conducting clinical investigations; any other 
proposed use requires written consent from Jazz Pharmaceuticals. Acceptance of this 
document constitutes an agreement by the recipient(s) that no unpublished information 
contained herein will be published or disclosed without first obtaining written approval from 
Jazz Pharmaceuticals, Inc. This document may be disclosed to appropriate Investigational 
Review Boards/Ethics Committees under the condition of confidentiality.
This study will be conducted under Good Clinical Practice guidelines.
CONFIDENTIAL
Page 1 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Signature Date: 20160429
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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SAFETY 
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STATISTICAL 
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CONFIDENTIAL
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
JZP-110
Jazz Pharmaceuticals
Clinical Trial Protocol: 15-004 Amendment 3  
 
  
CONFIDENTIAL
measures (SDLP) and PVT measures (lapses, mean reaction 
time, inverse reaction time). 
The incidence of treatment-emergent adverse events will be 
summarized by treatment. Descriptive statistics will be 
presented for vital sign results. No formal statistical testing will 
be performed for the safety analyses.
DATE OF 
ORIGINAL 
PROTOCOL
11 November 2015 
Amendment 1
18 March 2016
Amendment 2
19 April 2016
Amendment 3
28 April 2016
CONFIDENTIAL
Page 8 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
TABLE OF CONTENTS
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CONFIDENTIAL
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
-=3
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CONFIDENTIAL
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CONFIDENTIAL
Page 10 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 11 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Page 12 of 100


Signature Date: 20160429
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Page 13 of 100


Signature Date: 20160429
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CONFIDENTIAL
Page 17 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 18 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 19 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 20 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 21 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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1.4 
Summary of Potential Benefits and Risks 
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CONFIDENTIAL
Page 22 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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2
STUDY OBJECTIVES
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CONFIDENTIAL
Page 23 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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STUDY DESIGN
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Page 24 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
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JP: Protocol 15-004 Amendment 3.pdf
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Study Design
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Page 25 of 100


Signature Date: 20160429
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JP: Protocol 15-004 Amendment 3.pdf
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3.2
Rationale for Study Design 
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3.3 
Study Duration and Visit Locations 
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3.4 
End of Trial 
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4
STUDY POPULATION SELECTION
4.1 
Selection of Study Population 
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4.2 
Inclusion Criteria 
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CONFIDENTIAL
Page 26 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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4.3 
Exclusion Criteria 
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CONFIDENTIAL
Page 27 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 28 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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4.4 
Screening and Randomization Eligibility  
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5
STUDY TREATMENTS
5.1 
Description of Treatment(s) 
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5.2
Treatments Administered 
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5.3 
Selection and Timing of Dose for Each Subject 
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CONFIDENTIAL
Page 29 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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5.4 
Method of Assigning Subjects to Treatment Groups 
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Randomization 
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CONFIDENTIAL
Page 30 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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5.6 
Blinding 
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5.7 
Prior and Concomitant Therapy 
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CONFIDENTIAL
Page 31 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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5.8 
Treatment Compliance 
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Packaging and Labeling 
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CONFIDENTIAL
Page 32 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
JZP-110
Jazz Pharmaceuticals
Clinical Trial Protocol: 15-004 Amendment 3  
 
  
CONFIDENTIAL
6
STUDY PROCEDURES
6.1 
Recruitment and Informed Consent 
Investigators at the Clinical Sites (treating physicians) will recruit subjects from their clinical 
practice. 
Potentially eligible subjects will be approached during a regular visit to the hospital by a 
Clinical Site Investigator to bring the study to their attention and ask if the subject agrees to 
be contacted by the designated staff member (e.g., study nurse) for further information.
Interested subjects will receive further information and the Informed Consent Form (ICF) 
from the study nurse. The study nurse will also ask if the subject agrees to be contacted by 
phone after a minimum of 7 days to ask if they remain interested.  
Subjects may also be contacted by mail or email with the ICF attached to a message to
consider participation in the study and will be instructed to contact the study nurse, if
interested.
Interested subjects who receive an Informed Consent Form (ICF) will be asked to carefully
read and review the form and to ask the designated staff member (e.g., study nurse) by phone 
and/or email for any explanations or answers to any questions that they might have. Subjects 
will be given at least 7 days to consider their decision to participate. Subjects will be
informed that participation in the study is voluntary, that they may stop during the study, and 
that if they stop or choose not to participate, they do not have to give any reasons for 
stopping and will be treated for OSA as appropriate. If the subject has any specific questions 
regarding the driving tests that the Investigator or designated staff member (e.g., study nurse) 
at the Clinical Site cannot answer, the subject will be put in contact with the Driving Site 
Investigators or designated staff at the Driving Test Site to answer the question. At the 
Screening Visit, the ICF and study procedures will be reviewed again with the subject by the 
designated staff member (e.g., study nurse) and the subject will be given a further 
opportunity to ask questions prior to voluntarily signing the ICF and prior to initiating any 
study related procedures. 
Subjects who wish to receive more information about the study can also contact the 
independent medical doctor listed in the ICF, who is fully informed about the study but is not 
affiliated with the Sponsor or the study itself.
Each subject will be given a copy of his or her signed informed consent form (ICF). Each 
subject’s chart will have his or her signed ICF for study participation attached to it. A copy of 
the informed consent obtained at the Clinical Site will be forwarded to the Driving Test Site 
and each Clinical Site where study procedures are to be performed prior to Visit 2 or 3. Each 
site will retain a copy of the ICF in its central study file.
6.2 
Demographics 
Demographic information will be collected at Screening as permitted by regional or national 
regulations. Demographics will include the date the subject signed the informed consent, and 
the subject’s age (as indicated by date of birth, month and year of birth, year of birth, or age 
at screening), sex, ethnicity, and race.  
CONFIDENTIAL
Page 33 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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6.3 
Medical History 
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Physical Examination 
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6.5 
Vital Signs  
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6.6 
Electrocardiography 
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CONFIDENTIAL
Page 34 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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6.7 
Epworth Sleepiness Scale (ESS) 
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6.8 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
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6.9 
Maintenance of Wakefulness Test (MWT) 
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6.10 Sleep Diary 
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6.11 Actigraphy 
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CONFIDENTIAL
Page 35 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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6.12 Toronto Hospital Alertness Test (THAT) 
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6.13
Primary OSA Therapy Use and Recording 
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6.14
Clinical Laboratory Tests
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CONFIDENTIAL
Page 36 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Table 1 List of Laboratory Tests
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CONFIDENTIAL
Page 37 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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6.15 Dispensing Study Drug 
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Efficacy Assessments
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Page 38 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
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JP: Protocol 15-004 Amendment 3.pdf
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Page 39 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Page 40 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Page 41 of 100


Signature Date: 20160429
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Signature Date:
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CONFIDENTIAL
Page 42 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 43 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 44 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 45 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 46 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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7
STUDY ACTIVITIES
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CONFIDENTIAL
Page 47 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 48 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 49 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 50 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 51 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 52 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 53 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 54 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 55 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Early Termination 
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QUALITY CONTROL AND ASSURANCE
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PLANNED STATISTICAL METHODS
9.1 
General Considerations 
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Tests of Hypotheses and Significance Levels 
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CONFIDENTIAL
Page 56 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Determination of Sample Size 
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Analysis Populations  
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Demographics and Baseline Characteristics 
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9.6 
Handling of Dropouts and Missing Data 
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CONFIDENTIAL
Page 57 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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9.7 
Efficacy Endpoint(s) 
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Safety Endpoint(s) 
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9.9
Efficacy Analyses 
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CONFIDENTIAL
Page 58 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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9.10
Safety Analyses 
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CONFIDENTIAL
Page 59 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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9.11
Exploratory Analyses
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CONFIDENTIAL
Page 60 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Subgroup Analyses
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Case Report Forms 
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CONFIDENTIAL
Page 61 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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9.17 Retention of Data 
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10 ADMINISTRATIVE CONSIDERATIONS
10.1 Investigators and Study Administrative Structure 
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CONFIDENTIAL
Page 62 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 63 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 64 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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10.6 Incentives 
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10.7 Subject Confidentiality  
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10.8
Protocol Adherence – Amendments 
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10.9 Required Documents 
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10.10 Study Monitoring 
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CONFIDENTIAL
Page 65 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
JZP-110
Jazz Pharmaceuticals
Clinical Trial Protocol: 15-004 Amendment 3 
CONFIDENTIAL
10.11 Protocol Deviations
All major protocol violations must be reported to the ethics committee in an expedited 
fashion. It is the responsibility of the principal investigator to ensure proper reporting to the 
ethics committee. All protocol violations and deviations must be reported to Jazz 
Pharmaceuticals or designee. 
10.12 Access to Source Documentation 
The investigator/institution will permit trial-related monitoring (Section 10.10), audits 
conducted by the Clinical Quality Assurance Department of Jazz Pharmaceuticals or 
designee, ethics committee review and regulatory inspections by providing direct access to 
source data and documents for the trial. 
10.13 Handling and Storage of Data and Documents 
Subject data will be handled confidentially and coded. Each subject will be assigned a unique 
subject identification (ID [the “code”]). The key to the code, i.e., the linkage between the 
subject ID and the actual subject, is held at the investigational site, and can only be accessed 
by site staff and those monitoring the site. The key to the code will be safeguarded by the 
investigator or an independent person or committee. In addition to the research team, other 
parties (e.g., the ethics committee, monitors, or regulatory inspectors) may have access to the 
study data. The investigators will store the data and study documents (including but not 
limited to the source data) for 15 years after the end of the study (i.e., 15 years after last 
subject, last visit). The sponsor will receive a coded copy of the data which will be stored on 
a secure, limited access computer server at the Contract Research Organization and at Jazz 
Pharmaceuticals. The sponsor will retain these data for a maximum period of 15 years after 
the end of the study.  
10.14 Annual Progress Report 
The sponsor/investigator will submit a summary of the progress of the trial to the accredited 
METC once a year. Information will be provided on the date of inclusion of the first subject, 
numbers of subjects included and numbers of subjects that have completed the trial, serious 
adverse events/ serious adverse reactions, other problems, and amendments. 
10.15 Publication and Disclosure Policy 
Please refer to individual site contracts for specific contractual obligations and requirements. 
All information concerning JZP-110, Jazz Pharmaceuticals’ operations, patent applications, 
formulas, manufacturing processes, basic scientific data, and formulation information 
supplied by Jazz Pharmaceuticals to the investigator and not previously published, are 
considered confidential and remain the sole property of Jazz Pharmaceuticals. CRFs also 
remain the property of Jazz Pharmaceuticals. The investigator agrees to use this information 
only to complete this study and will not use it for other purposes except as further detailed in 
the Clinical Study Agreement signed by the investigator and/or institution.
CONFIDENTIAL
Page 66 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 67 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
11 REFERENCE LIST
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CONFIDENTIAL
Page 68 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 69 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 70 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 71 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 72 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 1 
Schedule of Events 
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2
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CONFIDENTIAL
Page 73 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 74 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 75 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 2 
Example Schedule of Times for Procedures During 
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Nominal 
time
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clock time
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CONFIDENTIAL
Page 76 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 3 
ICSD-3 Diagnostic Criteria for OSA 
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Diagnostic Criteria
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CONFIDENTIAL
Page 77 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 4 
DSM-5 Criteria for Psychiatric Disorders 
The following selected psychiatric DSM-5 criteria are presented as a resource, if needed 
when screening subjects. The full DSM Edition 5 (DSM-5) criteria for psychiatric conditions 
should be consulted for diagnoses not listed here. 
Bipolar and Related Disorders
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CONFIDENTIAL
Page 78 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 79 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Bipolar I Disorder
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Bipolar II Disorder
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CONFIDENTIAL
Page 80 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 81 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 82 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 83 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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CONFIDENTIAL
Page 84 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 5 
Epworth Sleepiness Scale (ESS) 
CONFIDENTIAL
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
Epworth Sleepiness Scale 
 
 
Name: ______________________________________________ Today’s date: _________________ 
 
Your age (Yrs): _______________ Your  sex (Male = M, Female = F): ________ 
 
 
How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just 
tired? 
 
This refers to your usual way of life in recent times. 
 
Even if you haven’t done some of these things recently try to work out how they would have affected 
you. 
 
Use the following scale to choose the most appropriate number for each situation: 
           
0  =  would never doze 
1  =  slight chance of dozing 
2  =  moderate chance of dozing 
3  =  high chance of dozing 
 
It is important that you answer each question as best you can. 
 
Situation 
 
 
 
 
 
 
 
Chance of Dozing (0-3) 
 
 
 
Sitting and reading        ________________________________________ 
  
 
Watching TV                ________________________________________ 
 
 
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 the traffic  ________________ 
 
 
 
 
THANK YOU FOR YOUR COOPERATION 
 
 
¤ M.W. Johns  1990-97 
 
 
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___ 
CONFIDENTIAL
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 6 
Columbia-Suicide Severity Rating-Baseline/Screening 
Version 
CONFIDENTIAL
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
COLUMBIA-SUICIDE SEVERITY
RATING SCALE
(C-SSRS)
Baseline/Screening Version 
Version 1/14/09 
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained in 
the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of suicidal 
ideation or behavior depends on the judgment of the individual administering the scale. 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History Form, 
developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu
© 2008 The Research Foundation for Mental Hygiene, Inc. 
CONFIDENTIAL
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Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
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SUICIDAL IDEATION
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to 
question 2 is “yes”, ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete 
“Intensity of Ideation” section below.
Lifetime: Time 
He/She Felt 
Most Suicidal
Past __
Months
1.  Wish to be Dead
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up. 
Have you wished you were dead or wished you could go to sleep and not wake up? 
If yes, describe:
Yes      No
□    □
Yes     No
□   □
2.  Non-Specific Active Suicidal Thoughts
General non-specific thoughts of wanting to end one’s life/commit suicide (e.g., “I’ve thought about killing myself”) without thoughts 
of ways to kill oneself/associated methods, intent, or plan during the assessment period. 
Have you actually had any thoughts of killing yourself?
If yes, describe:
Yes     No
□  □
Yes     No
□   □
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period. This is different than a 
specific plan with time, place or method details worked out (e.g.  thought of method to kill self but not a specific plan).  Includes person 
who would say, “I thought about taking an overdose but I never made a specific plan as to when, where or how I would actually do 
it…and I would never go through with it.”
Have you been thinking about how you might do this?
If yes, describe:
Yes     No
□    □
Yes     No
□   □
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the 
thoughts but I definitely will not do anything about them.”
Have you had these thoughts and had some intention of acting on them?
If yes, describe:
Yes      No
□    □
Yes     No
□   □
5.  Active Suicidal Ideation with Specific Plan and Intent
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out.
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?
   
If yes, describe:
Yes    No
□    □
Yes     No
□   □
INTENSITY OF IDEATION
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being 
the least severe and 5 being the most severe). Ask about time he/she was feeling the most suicidal. 
                                  
Lifetime -           Most Severe Ideation:  _______                ________________________________________
                                                                      Type # (1-5)                                                 Description of  Ideation
Past X Months - Most Severe Ideation:  _______                  ________________________________________
                                                                     Type # (1-5)                                                 Description of  Ideation
Most 
Severe 
Most 
Severe 
Frequency
How many times have you had these thoughts?
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day
____
____
Duration
When you have the thoughts how long do they last?
(1) Fleeting - few seconds or minutes                                                 (4) 4-8 hours/most of day
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous
(3) 1-4 hours/a lot of time
____
____
Controllability
Could/can you stop thinking about killing yourself or wanting to die if you want to?
(1) Easily able to control thoughts                                                      (4) Can control thoughts  with a lot of difficulty
(2) Can control thoughts with little difficulty                                     (5) Unable to control thoughts
(3) Can control thoughts with some difficulty                                    (0) Does not attempt to control thoughts
____
____
Deterrents
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to 
die or acting on thoughts of committing suicide?
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you 
(2) Deterrents probably stopped you                                                    (5) Deterrents definitely did not stop you 
(3) Uncertain that deterrents stopped you                                             (0) Does not apply
____
____
Reasons for Ideation
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain 
or stop the way you were feeling (in other words you couldn’t go on living with this pain or how you were 
feeling) or was it to get attention, revenge or a reaction from others? Or both?
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling)
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on 
       and to end/stop the pain                                                                         living with the pain or  how you were feeling)
                                                                                                                 (0) Does not apply
____
____
© 2008 Research Foundation for Mental Hygiene, Inc.
        C-SSRS—Baseline/Screening (Version 1/14/09)   
                            Page 1 of 2     
CONFIDENTIAL
Page 89 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
SUICIDAL BEHAVIOR
(Check all that apply, so long as these are separate events; must ask about all types)
Lifetime
Past __
Years
Actual Attempt:
A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill 
oneself. Intent does not have to be 100%.  If there is any intent/desire to die associated with the act, then it can be considered an actual suicide 
attempt. There does not have to be any injury or harm, just the potential for injury or harm. If person pulls trigger while gun is in 
mouth but gun is broken so no injury results, this is considered an attempt.  
Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances. For example, a 
highly lethal act that is clearly not an accident so no other intent but suicide can be inferred (e.g., gunshot to head, jumping from window of a 
high floor/story). Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred. 
Have you made a suicide attempt?
Have you done anything to harm yourself?
Have you done anything dangerous where you could have died?
What did you do?
Did you______ as a way to end your life? 
Did you want to die (even a little) when you_____? 
Were you trying to end your life when you _____?
Or Did you think it was possible you could have died from_____?
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better, 
get sympathy, or get something else to happen)? (Self-Injurious Behavior without suicidal intent)
If yes, describe:
Has subject engaged in Non-Suicidal Self-Injurious Behavior?
Yes     No
□   □
Total # of
Attempts
______
Yes     No
□   □
Yes     No
□   □
Total # of
Attempts
______
Yes     No
□   □
Interrupted Attempt:
When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would 
have occurred).
Overdose: Person has pills in hand but is stopped from ingesting.  Once they ingest any pills, this becomes an attempt rather than an interrupted 
attempt. Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger. Once 
they pull the trigger, even if the gun fails to fire, it is an attempt. Jumping: Person is poised to jump, is grabbed and taken down from ledge. 
Hanging: Person has noose around neck but has not yet started to hang - is stopped from doing so.
Has there been a time when you started to do something to end your life but someone or something stopped you before 
you actually did anything?
If yes, describe:
Yes      No
□   □
Total # of 
interrupted
______
Yes     No
□   □
Total # of 
interrupted
______
Aborted Attempt:  
When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-
destructive behavior. Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by 
something else.
Has there been a time when you started to do something to try to end your life but you stopped yourself before you 
actually did anything?
If yes, describe:
Yes      No
□   □
Total # of
aborted
______
Yes     No
□   □
Total # of
aborted
______
Preparatory Acts or Behavior:
Acts or preparation towards imminently making a suicide attempt. This can include anything beyond a verbalization or thought, such as 
assembling a specific method (e.g., buying pills, purchasing a gun) or preparing for one’s death by suicide (e.g., giving things away, writing a 
suicide note). 
Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, 
getting a gun, giving valuables away or writing a suicide note)?
If yes, describe:
Yes      No
□   □
Yes     No
□   □
Suicidal Behavior:
Suicidal behavior was present during the assessment period?
Yes      No
□   □
Yes     No
□   □
Answer for Actual Attempts Only
Most Recent 
Attempt
Date:
Most Lethal        
Attempt
Date:
Initial/First 
Attempt
Date:
Actual Lethality/Medical Damage:  
0.  No physical damage or very minor physical damage (e.g., surface scratches).
1.  Minor physical damage (e.g., lethargic speech; first-degree burns; mild bleeding; sprains).
2.  Moderate physical damage; medical attention needed (e.g., conscious but sleepy, somewhat responsive; second-degree 
burns; bleeding of major vessel).
3.  Moderately severe physical damage; medical hospitalization and likely intensive care required (e.g., comatose with reflexes 
intact; third-degree burns less than 20% of body; extensive blood loss but can recover; major fractures).
4.  Severe physical damage; medical hospitalization with intensive care required (e.g., comatose without reflexes; third-degree 
burns over 20% of body; extensive blood loss with unstable vital signs; major damage to a vital area).
5.  Death
Enter Code
______
Enter Code
______
Enter Code
______
Potential Lethality: Only Answer if Actual Lethality=0
Likely lethality of actual attempt if no medical damage (the following examples, while having no actual medical damage, had 
potential for very serious lethality: put gun in mouth and pulled the trigger but gun fails to fire so no medical damage; laying 
on train tracks with oncoming train but pulled away before run over).
0 = Behavior not likely to result in injury
1 = Behavior likely to result in injury but not likely to cause death
2 = Behavior likely to result in death despite available medical care
Enter Code
______
Enter Code
______
Enter Code
______
© 2008 Research Foundation for Mental Hygiene, Inc.
        C-SSRS—Baseline/Screening (Version 1/14/09)   
                             Page 2 of 2     
CONFIDENTIAL
Page 90 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 7 
Columbia-Suicide Severity Rating-Since Last Visit 
Version
CONFIDENTIAL
Page 91 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
COLUMBIA-SUICIDE SEVERITY
RATING SCALE
(C-SSRS) 
Since Last Visit 
Version 1/14/09 
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained 
in the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of 
suicidal ideation or behavior depends on the judgment of the individual administering the scale. 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History 
Form, developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu
 
© 2008 The Research Foundation for Mental Hygiene, Inc. 
CONFIDENTIAL
Page 92 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
SUICIDAL IDEATION
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to question 2 is “yes”,
ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete “Intensity of Ideation” section below.
Since Last 
Visit
1.  Wish to be Dead
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up. 
Have you wished you were dead or wished you could go to sleep and not wake up? 
If yes, describe:
Yes   
No
□  □
2.  Non-Specific Active Suicidal Thoughts
General, non-specific thoughts of wanting to end one’s life/commit suicide (e.g., “I’ve thought about killing myself”) without thoughts of ways to kill 
oneself/associated methods, intent, or plan during the assessment period. 
Have you actually had any thoughts of killing yourself?
If yes, describe:
Yes      No
□    □
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period. This is different than a specific plan with time, 
place or method details worked out (e.g., thought of method to kill self but not a specific plan).  Includes person who would say, “I thought about taking an
overdose but I never made a specific plan as to when, where or how I would actually do it…and I would never go through with it.”
Have you been thinking about how you might do this?
If yes, describe:
Yes      No
□  □
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the thoughts but I 
definitely will not do anything about them.”
Have you had these thoughts and had some intention of acting on them?
If yes, describe:
Yes     No
□   □
5.  Active Suicidal Ideation with Specific Plan and Intent
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out.
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?
   
If yes, describe:
Yes     No
□  □
INTENSITY OF IDEATION
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being the least severe 
and 5 being the most severe). 
                                            
Most Severe Ideation:             _____                      _________________________________________________
                                             
                                                                                                          Type # (1-5)                                         Description of  Ideation
Most 
Severe
Frequency
How many times have you had these thoughts?
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day
____
Duration
When you have the thoughts, how long do they last?
(1) Fleeting - few seconds or minutes                                             
(4) 4-8 hours/most of day
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous
(3) 1-4 hours/a lot of time                                                                   
____
Controllability
Could/can you stop thinking about killing yourself or wanting to die if you want to?
(1) Easily able to control thoughts                                                      (4) Can control thoughts with a lot of difficulty
(2) Can control thoughts with little difficulty                                   (5) Unable to control thoughts
(3) Can control thoughts with some difficulty                                   (0) Does not attempt to control thoughts
____
Deterrents
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to die or acting on 
thoughts of committing suicide?
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you 
(2) Deterrents probably stopped you                                                
(5) Deterrents definitely did not stop you 
(3) Uncertain that deterrents stopped you                                            (0) Does not apply
____
Reasons for Ideation
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain or stop the way 
you were feeling (in other words you couldn’t go on living with this pain or how you were feeling) or was it to get attention,
revenge or a reaction from others? Or both?
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling)
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on 
       and to end/stop the pain                                                                         living with the pain or  how you were feeling)
                                                                                                                 (0) Does not apply
____
© 2008 Research Foundation for Mental Hygiene, Inc.
        C-SSRS—Since Last Visit (Version 1/14/09)
                         Page 1 of 2       
CONFIDENTIAL
Page 93 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
SUICIDAL BEHAVIOR
(Check all that apply, so long as these are separate events; must ask about all types)
Since Last 
Visit
Actual Attempt:
A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill oneself. Intent 
does not have to be 100%.  If there is any intent/desire to die associated with the act, then it can be considered an actual suicide attempt. There does not 
have to be any injury or harm, just the potential for injury or harm. If person pulls trigger while gun is in mouth but gun is broken so no injury results,
this is considered an attempt.  
Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances. For example, a highly 
lethal act that is clearly not an accident so no other intent but suicide can be inferred (e.g., gunshot to head, jumping from window of a high floor/story). 
Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred. 
Have you made a suicide attempt?
Have you done anything to harm yourself?
Have you done anything dangerous where you could have died?
What did you do?
Did you______ as a way to end your life? 
Did you want to die (even a little) when you_____? 
Were you trying to end your life when you _____?
Or did you think it was possible you could have died from_____?
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better, get
sympathy, or get something else to happen)? (Self-Injurious Behavior without suicidal intent)
If yes, describe:
Has subject engaged in Non-Suicidal Self-Injurious Behavior?
Yes      No
□   □
Total # of
Attempts
______
Yes
No
□   □
Interrupted Attempt:
When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have 
occurred).
Overdose: Person has pills in hand but is stopped from ingesting.  Once they ingest any pills, this becomes an attempt rather than an interrupted attempt. 
Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger. Once they pull the trigger, 
even if the gun fails to fire, it is an attempt. Jumping: Person is poised to jump, is grabbed and taken down from ledge. Hanging: Person has noose around 
neck but has not yet started to hang - is stopped from doing so.
Has there been a time when you started to do something to end your life but someone or something stopped you before you 
actually did anything?
If yes, describe:
Yes      No
□   □
Total # of 
interrupted
______
Aborted Attempt:  
When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior. 
Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by something else.
Has there been a time when you started to do something to try to end your life but you stopped yourself before you 
actually did anything?
If yes, describe:
Yes      No
□   □
Total # of
aborted
______
Preparatory Acts or Behavior:
Acts or preparation towards imminently making a suicide attempt. This can include anything beyond a verbalization or thought, such as assembling a 
specific method (e.g., buying pills, purchasing a gun) or preparing for one’s death by suicide (e.g., giving things away, writing a suicide note). 
Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, getting a gun, 
giving valuables away or writing a suicide note)?
If yes, describe:
Yes      No
□   □
Suicidal Behavior:
Suicidal behavior was present during the assessment period?
Yes      No
□   □
Suicide:
Yes    No
□   □
Answer for Actual Attempts Only
Most Lethal
Attempt
Date:
Actual Lethality/Medical Damage:  
0.  No physical damage or very minor physical damage (e.g., surface scratches).
1.  Minor physical damage (e.g., lethargic speech; first-degree burns; mild bleeding; sprains).
2.  Moderate physical damage; medical attention needed (e.g., conscious but sleepy, somewhat responsive; second-degree burns; bleeding of major vessel).
3.  Moderately severe physical damage; medical hospitalization and likely intensive care required (e.g., comatose with reflexes intact; third-degree burns 
less than 20% of body; extensive blood loss but can recover; major fractures).
4.  Severe physical damage; medical hospitalization with intensive care required (e.g., comatose without reflexes; third-degree burns over 20% of body; 
extensive blood loss with unstable vital signs; major damage to a vital area).
5.  Death
Enter Code
______
Potential Lethality: Only Answer if Actual Lethality=0
Likely lethality of actual attempt if no medical damage (the following examples, while having no actual medical damage, had potential for very serious 
lethality: put gun in mouth and pulled the trigger but gun fails to fire so no medical damage; laying on train tracks with oncoming train but pulled away 
before run over).
0 = Behavior not likely to result in injury
1 = Behavior likely to result in injury but not likely to cause death
2 = Behavior likely to result in death despite available medical care 
Enter Code
______
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Since Last Visit (Version 1/14/09)    
 
 
                          Page 2 of 2                           
CONFIDENTIAL
Page 94 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 8 
Sleep Diary 

CONFIDENTIAL
Page 95 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf

Subject No:
Sleep Diary
Example
Mark arrows on the grid to indicate daily Sleep (S) times. Fill in the date at the top of each column.
01/03/16
Date
Sunday
Time
Sunday
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
12:00 - 12:30
12:30 - 13:00
13:00 - 13:30
13:30 - 14:00
14:00 - 14:30
14:30 - 15:00
15:00 - 15:30
15:30 - 16:00
16:00 -1 6:30
16:30 - 17:00
S
17:00 - 17:30
17:30 - 18:00
18:00 - 18:30
18:30 - 19:00
19:00 - 19:30
19:30 - 20:00
20:00 - 20:30
20:30 - 21:00
21:00 - 21:30
21:30 - 22:00
22:00 - 22:30
22:30 - 23:00
23:00 - 23:30
23:30 - 00:00
00:00 - 00:30
00:30 - 01:00
01:00 - 01:30
01:30 - 02:00
               
02:00 - 02:30
02:30 - 03:00
S
03:00 - 03:30
03:30 - 04:00
04:00 - 04:30
04:30 - 05:00
05:00 - 05:30
05:30 - 06:00
06:00 - 06:30
06:30 - 07:00
07:00 - 07:30
07:30 - 08:00
08:00 - 08:30
08:30 - 09:00
09:00 - 09:30
09:30 - 10:00
10:00 - 10:30
10:30 - 11:00
11:00 - 11:30
11:30 - 12:00
CONFIDENTIAL
Page 96 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Toronto Hospital Alertness Test (THAT) 
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CONFIDENTIAL
Page 97 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 10
OSA Primary Therapy Use Diary
Please complete the diary each morning. For example, record your information for Sunday evening in the Sunday column. 
  No use of a primary OSA therapy device during the duration of the subject’s participation in the trial, confirmed.  (Please leave remainder of 
form blank).  
Day of the Week: 
 
 
 
 
 
 
 
 
Date 
(DD/MMM/YYYY) 
__/____/__ __/____/__ __/____/__ __/____/__ __/____/__ __/____/__ __/____/__ __/____/__ 
Did you use a primary 
OSA therapy (PAP or 
oral appliance) on the 
following 
ġYes ġNo
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
 
If yes, did you use it 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
Date 
(DD/MMM/YYYY) 
__/____/__ __/____/__ __/____/__ __/____/__ __/____/__ __/____/__ __/____/__ __/____/__ 
Did you use a primary 
OSA therapy (PAP or 
oral appliance) on the 
following: 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
ġYes ġNo 
If yes, did you use it 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
ġMore than 
half the night? 
ġLess than 
half the night? 
ġunknown 
PLEASE, REMEMBER TO BRING YOUR DIARY CARD TO EACH CLINIC VISIT. 
CONFIDENTIAL
Page 98 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
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Appendix 11 
DSM-5 Substance Use Disorder Diagnostic Criteria 
The following criteria are adapted from the DSM-5 criteria for substance use disorders and 
are presented as a resource, if needed when screening subjects. The full DSM Edition 5 
(DSM-5) criteria for substance use disorders should be consulted for further information.
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CONFIDENTIAL
Page 99 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Date:
JP: Protocol 15-004 Amendment 3.pdf
JZP-110
Jazz Pharmaceuticals
Clinical Trial Protocol: 15-004 Amendment 3 
 
  
Appendix 12 
Signatures of Agreement for Protocol 
Study Title:
A Randomized, Double-Blind, Placebo-Controlled, Crossover On-
Road Driving Study Assessing the Effect of JZP-110 on Driving 
Performance in Subjects with Excessive Sleepiness Due to 
Obstructive Sleep Apnea  
Study Number:
15-004
Original Protocol:
11 November 2015
Amendment 1:
18 March 2016
Amendment 2:
19 April 2016
Amendment 3:
28 April 2016
This clinical study protocol was subject to critical review and has been approved by Jazz 
Pharmaceuticals.
CONFIDENTIAL
Page 100 of 100


Signature Date: 20160429
JP: Protocol 15-004 Amendment 3.pdf
Signature Manifestation

SAP_001.pdf: