"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:11/22/2017
Start Date:May 2015
End Date:November 2016

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A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter
study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult
subjects with OSA.


Major Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive

2. Diagnosis of OSA according to ICSD-3 criteria

3. Body mass index from 18 to <45 kg/m2

4. Consent to use a medically acceptable method of contraception

5. Willing and able to provide written informed consent

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating.

2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
OSA that is associated with excessive sleepiness

3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
criteria

4. History or presence of any acutely unstable medical condition, behavioral or
psychiatric disorder (including active suicidal ideation), or surgical history that
could affect the safety of the subject or interfere with study efficacy or safety
assessments or the ability of the subject to complete the trial per the judgment of
the principal investigator

5. History of bariatric surgery within the past year or a history of any gastric bypass
procedure

6. Presence or history of significant cardiovascular disease

7. Use of any over the counter (OTC) or prescription medications that could affect the
evaluation of excessive sleepiness

8. Received an investigational drug in the past 30 days or five half-lives (whichever is
longer)

9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05,
R228060, or YKP10A)

10. History of phenylketonuria (PKU) or history of hypersensitivity to
phenylalanine-derived products
We found this trial at
23
sites
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Naresh Punjabi, MD
Phone: 410-550-0571
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Susan Redline, MD
Phone: 857-307-0339
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Atlanta, Georgia 30329
Principal Investigator: Nancy Collop, MD
Phone: 404-712-7533
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Birmingham, Alabama 35213
Principal Investigator: Robert Doekel, MD
Phone: 205-599-1020
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Brandon, Florida 33511
Principal Investigator: Daniel Lorch, MD
Phone: 813-657-1854
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Charleston, South Carolina 29406
Principal Investigator: Thomas Kaelin, MD
Phone: 843-572-8545
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Chitra Lal, MD
Phone: 843-792-4349
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Andrew Krystal, MD
Phone: 919-681-0934
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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7261 Sheridan Street
Hollywood, Florida 33024
Principal Investigator: David Seiden, MD
Phone: 954-374-1150
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Lakewood, Colorado 80228
Principal Investigator: Stephen Duntely, MD
Phone: 303-765-3536
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Lenexa, Kansas 66214
Principal Investigator: Vernon Rowe, MD
Phone: 913-827-4216
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Metairie, Louisiana 70006
Principal Investigator: Morteza Shamsnia, MD
Phone: 601-341-9130
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Norfolk, Virginia 23510
Principal Investigator: J. Catesby Ware, MD
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Oceanside, California
Principal Investigator: Michael Zupancic, MD
Phone: 760-732-0557
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Orange, California 92868
Principal Investigator: Andrew Schreiber, MD
Phone: 714-834-1565
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Oviedo, Florida 32765
Principal Investigator: Bradley Block
Phone: 407-977-2705
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Philadelphia, Pennsylvania 19104
Principal Investigator: Richard Schwab, MD
Phone: 215-614-1807
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Rachel Givelber, MD
Phone: 412-864-6371
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Santa Monica, California 90404
Principal Investigator: Daniel Norman, MD
Phone: 310-586-0843
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Tampere, Södra Finlands län 33200
Principal Investigator: Olli Polo
Phone: 358-50-3054-739
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Topeka, Kansas 66606
Principal Investigator: William Leeds, MD
Phone: 785-354-0735
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Vienna, Virginia 22182
Principal Investigator: Guillermo Giangreco, MD
Phone: 703-204-1180
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Principal Investigator: Mitchell Lee, MD
Phone: 910-815-6108
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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