"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
NCT ID: NCT02348593
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
239 participants
INTERVENTIONAL
2015-05-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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75 mg of JZP-110
Once Daily Dosing
JZP-110
150 mg JZP-110
Once Daily Dosing
JZP-110
300 mg of JZP-110
Once Daily Dosing
JZP-110
Placebo
Once Daily Dosing
Placebo oral tablet
Interventions
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JZP-110
Placebo oral tablet
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 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
Exclusion Criteria
2. Moderate or severe sleep apnea on the baseline PSG.
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. 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
6. History of bariatric surgery within the past year or a history of any gastic bypass procedure
7. Presence or history of significant cardiovascular disease
8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
9. Use of any medications that could affect the evaluation of cataplexy
10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
12. 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
So Cal Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States
Pacific Sleep Medicine
Oceanside, California, United States
SDS Clinical Trials
Orange, California, United States
Stanford University Center for Narcolepsy
Redwood City, California, United States
Pacific Research Network, Inc.
San Diego, California, United States
Critical Care Pulmonary & Sleep Associates, LLC
Lakewood, Colorado, United States
MD Clinical
Hallandale, 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
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 Chicago, College of Nursing
Chicago, Illinois, United States
Veritas Clinical Specialties LTD
Topeka, Kansas, United States
Kentucky Research Group
Louisville, Kentucky, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Neurocare, Inc.
Newton, Massachusetts, United States
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States
Minnesota Lung Center
Edina, Minnesota, 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
Montefiore Medical center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, 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
North Coast Clinical Trials Inc.
Beachwood, Ohio, United States
Sleep Management Institute
Cincinnati, 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
Lowcountry Lung Critical Care
Charleston, South Carolina, United States
Sleep Med of South Carolina
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
Swedish Medical Center
Seattle, Washington, United States
London Health Sciences Centre
London, 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
Helsinki Sleep Clinic
Helsinki, , Finland
Hospital Roger Salengro
Lille, , France
Universite Paris 5 Hôtel-Dieu
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
Regensburg, Bavaria, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Advanced Sleep Research GmbH
Berlin, , Germany
Studienzentrum Wilhelmshoehe
Kassel, , Germany
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, , Germany
Sleep Wake Center SEIN Heemstede
Heemstede, North Holland, Netherlands
Countries
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References
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Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.
Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006.
Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.
Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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14-002
Identifier Type: -
Identifier Source: org_study_id
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