"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
NCT ID: NCT02348632
Last Updated: 2019-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
645 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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75 mg - 300 mg of JZP-110
Once Daily Dosing
JZP-110
Interventions
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JZP-110
Eligibility Criteria
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Inclusion Criteria
1. Completed Study 14-002 or 14-003 (Group A)
2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to \<45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. Willing and able to provide written informed consent
Exclusion Criteria
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or 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. 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 Investigator
5. History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
18 Years
75 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Pulmonary Associates
Glendale, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
UC San Diego Medical Center
La Jolla, California, United States
So Cal Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States
Pacific Sleep Medicine
Oceanside, California, United States
The Research Center of Southern California
Oceanside, California, United States
Stanford University Center for Narcolepsy
Redwood City, California, United States
Pacific Research Network Inc.
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Critical care Pulmonary & Sleep Associates, LLC
Lakewood, Colorado, United States
MD Clinical
Hallandale, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States
Florida Pediatric Research Institute
Winter Park, Florida, United States
Emory Sleep Center
Atlanta, Georgia, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
SleepMed of Central Georgia
Macon, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Illinois at Chicago Nursing School
Chicago, Illinois, United States
Rowe Neurology Institute RNI - Lenexa
Lenexa, Kansas, United States
Veritas Clinical Specialties LTD
Topeka, Kansas, United States
Kentucky Research Group
Louisville, Kentucky, United States
Advanced Neurodiagnostic Center
Metairie, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Neurocare, Inc.
Newton, Massachusetts, United States
Henry Ford Hospital Sleep Disorders & Research Center
Detroit, Michigan, United States
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States
Minnesota Lung Center
Edina, Minnesota, United States
Sleep Medicine & Research center, St. Lukes Hospital
Chesterfield, Missouri, United States
University of Missouri
Columbia, Missouri, United States
Clayton Sleep Institute
St Louis, Missouri, United States
New York University Medical Center
New York, New York, United States
Clinilabs
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Hickory Research Center
Hickory, North Carolina, United States
Hickory Research Center, ARSM Research, LLC
Huntersville, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Northcoast Clinical Trials Inc.
Beachwood, Ohio, United States
Sleep Management Institute
Cincinnati, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Southwest Cleveland Sleep Research Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio Sleep Medicine & Neuroscience Institute
Dublin, Ohio, United States
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
Toledo, Ohio, United States
Center for Sleep and Circadian Neurobiology
Philadelphia, Pennsylvania, United States
UPMC Sleep Medicine Center
Pittsburgh, Pennsylvania, United States
Lowcountry Lung Critical Care
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Sleep Med of South Carolina Clinical Research Solutions
Columbia, South Carolina, United States
FutureSearch Trials of Neurology LP
Austin, Texas, United States
Todd J. Swick
Houston, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
EVMS Sleep Medicine
Norfolk, Virginia, United States
American Sleep Medicine
Vienna, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
London Health Sciences Centre
London, Ontario, Canada
Niagra Clinical Research
Niagra Falls, Ontario, Canada
Toronto Sleep Institute
Toronto, Ontario, Canada
Toronto Psychiatric Research Foundation
Toronto, Ontario, Canada
Pediatric Sleep Research Inc
Toronto, Ontario, Canada
CARSM Sleep Laboratory & Clinic
Montreal, Quebec, Canada
Unesta Research Center
Tampere, , Finland
University of Turku , Sleep Research Centre
Turku, , Finland
CHU de Dijon
Dijon, , France
Grenoble University Hospital
La Tronche, , France
Hospital Roger Salengro
Lille, , France
Universite Paris 5 Hôtel-Dieu
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
CHU de Poitiers
Poitiers, , France
Somnolab Dortmund
Dortmund, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Sleep Wake Center SEIN Heemstede
Heemstede, North Holland, Netherlands
Countries
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References
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Malhotra A, Strollo PJ Jr, Pepin JL, Schweitzer P, Lammers GJ, Hedner J, Redline S, Chen D, Chandler P, Bujanover S, Strohl K. Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. Sleep Med. 2022 Dec;100:165-173. doi: 10.1016/j.sleep.2022.08.005. Epub 2022 Aug 14.
Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.
Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.
Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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14-005
Identifier Type: -
Identifier Source: org_study_id
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