"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
NCT ID: NCT02348619
Last Updated: 2019-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2015-05-31
2016-11-30
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, 150, 300 mg of JZP-110
Once Daily Dosing
JZP-110
Placebo
Once Daily Dosing
JZP-110
Interventions
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JZP-110
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
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 Disorder Center of Alabama
Birmingham, Alabama, United States
The Research Center of Southern California
Oceanside, California, United States
SDS Clinical Trials, INC
Orange, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Critical Care Pulmonary & Sleep Associates, LLC
Lakewood, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Broward Research Group, Inc.
Hollywood, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Emory Sleep Center
Atlanta, Georgia, United States
Rowe Neurology Institute RNI - Lenexa
Lenexa, Kansas, United States
Veritas Clinical Specialities LTD
Topeka, Kansas, United States
Advanced Neurodiagnostic Ceneter
Metairie, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Center for Sleep & 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
EVMS Sleep Medicine
Norfolk, Virginia, United States
American Sleep Medicine
Vienna, Virginia, United States
Tampere University Hospital
Tampere, Södra Finlands Län, Finland
Turku University Hospital, Sleep Clinic
Turku, Västra Finlands Län, Finland
Helsinki Sleep Center
Helsinki, , Finland
Grenoble University Hospital
La Tronche, Auvergne-Rhône-Alpes, France
CHU de Poitiers
Poitiers, Vienne, France
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Somnolab Dortmund
Dortmund, North Rhine-Westphalia, Germany
Department of Sleep Medicine
Gӧteborg, Västra Götaland County, Sweden
Countries
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References
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Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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14-004
Identifier Type: -
Identifier Source: org_study_id
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