"Twelve-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:December 2016

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A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, 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 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm
parallel group 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, safety, PK
assessments, or the ability of the subject to complete the trial per the judgment of
the 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

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
46
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
Principal Investigator: Russell Rosenberg, MD
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Nancy Foldvary, MD
Phone: 216-444-6718
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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Austin, Texas 78731
Principal Investigator: JOhn Hudson, MD
Phone: 512-380-9925
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Alan Schwartz, MD
Phone: 410-550-2233
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Beachwood, Ohio 44122
Principal Investigator: Bijan Bastani, MD
Phone: 216-514-1803
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Brandon, Florida 33511
Principal Investigator: Daniel Lorch, MD
Phone: 813-657-1854
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232 South Woods Mill Road
Chesterfields, Missouri 63017
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Chevy Chase, Maryland 20815
Principal Investigator: Helene Emsellem, MD
Phone: 301-654-5665
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Chicago, Illinois 60612
Principal Investigator: Terri Weaver
Phone: 312-996-7808
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Phyllis Zee, MD
Phone: 312-908-8549
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Cincinnati, Ohio 45245
Principal Investigator: Bruce Corser, MD
Phone: 513-977-8891
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Cincinnati, Ohio 45227
Principal Investigator: James Maynard, MD
Phone: 513-281-3868
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Cleveland, Ohio 44130
Principal Investigator: Mansoor Ahmed, MD
Phone: 440-243-8044
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Kingman Strohl, MD
Phone: 216-844-5128
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Pradeep Sahota, MD
Phone: 573-884-0164
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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Columbia, South Carolina 29201
Principal Investigator: Richard Bogan, MD
Phone: 803-251-3093
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Detroit, Michigan 48202
Principal Investigator: Christopher Drake, MD
Phone: 313-916-5179
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Dublin, Ohio 43017
Principal Investigator: Markus Schmidt, MD
Phone: 614-766-0773
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Aatif Husain
Phone: 919-684-8485
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Edina, Minnesota 55435
Principal Investigator: Ralph Steele, MD
Phone: 952-852-5255
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Glendale, Arizona 85306
Principal Investigator: Mark Gotfried, MD
Phone: 602-298-1932
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Hickory, North Carolina 28602
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Houston, Texas 77063
Principal Investigator: Todd Swick, MD
Phone: 713-465-7066
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Huntersville, North Carolina 28078
Principal Investigator: Thomas Stern, MD
Phone: 704-817-2200
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La Jolla, California 92093
Principal Investigator: Atul Malhotra, MD
Phone: 617-983-7420
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Little Rock, Arkansas 72211
Principal Investigator: Paul Wylie, MD
Phone: 501-553-9987
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London, Ontario
Principal Investigator: Charles George, MD
Phone: 519 685 8500
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Los Angeles, California 90048
Principal Investigator: Roy Artal, MD
Phone: 310-657-1230
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Louisville, Kentucky 40217
Principal Investigator: David Winslow, MD
Phone: 502-459-9127
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Macon, Georgia 31201
Principal Investigator: Charles Wells, Jr., MD
Phone: 478-745-5779
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New York, New York 10019
Principal Investigator: Gary Zammit
Phone: 212-523-1700
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Newton, Massachusetts 02459
Principal Investigator: Robert Thomas, MD
Phone: 617-581-6403
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Oceanside, California 92054
Principal Investigator: Milton Erman, MD
Phone: 858-224-1851
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Raleigh, North Carolina 27607
Principal Investigator: Alvin Thomas Perkins, MD
Phone: 919-420-1658
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Redwood City, California 94063
Principal Investigator: Emmaunuel Mignot, MD
Phone: 650-721-5489
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Saint Louis, Missouri 63143
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Saint Petersburg, Florida 33707
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San Antonio, Texas 78229
Principal Investigator: James Andry, MD
Phone: 210-614-6000
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San Diego, California 92103
Principal Investigator: Stephen G Thein, PhD
Phone: 619-294-4302
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Lois Krahn, MD
Phone: 480-342-3987
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Sarah Stolz, MD
Phone: 206-215-3982
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Sterling Heights, Michigan 48314
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Toledo, Ohio 43606
Principal Investigator: Michael Neeb
Phone: 419-251-3232
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Winter Park, Florida 32789
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