"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT02348606
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 476
- Male or female between 18 and 75 years of age, inclusive
- Diagnosis of OSA according to ICSD-3 criteria
- Body mass index from 18 to <45 kg/m2
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Major
- Female subjects who are pregnant, nursing, or lactating
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- 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.
- History of bariatric surgery within the past year or a history of any gastric bypass procedure
- Presence or history of significant cardiovascular disease
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Received an investigational drug in the past 30 days or five half-lives
- Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 300 mg of JZP-110 JZP-110 Once Daily Dosing 37.5 mg of JZP-110 JZP-110 Once Daily Dosing 150 mg of JZP-110 JZP-110 Once Daily Dosing 75 mg of JZP-110 JZP-110 Once Daily Dosing Placebo Placebo oral tablet Once Daily Dosing
- Primary Outcome Measures
Name Time Method Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 Baseline to Week 12 Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Change in ESS Score From Baseline to Week 12 Baseline to Week 12 Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
- Secondary Outcome Measures
Name Time Method Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 12 Weeks Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
This is the key secondary endpoint.Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 Baseline and Week 12 Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 Baseline to Week 4 Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 Baseline to Weeks 1, 4, and 8 Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 Weeks 1, 4, and 8 Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 Week 12 Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 Weeks 1, 4, and 8 Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Trial Locations
- Locations (59)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
So Cal Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
Southwest Cleveland Sleep Research Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Todd J. Swick
🇺🇸Houston, Texas, United States
Pulmonary Associates
🇺🇸Glendale, Arizona, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
UC San Diego Medical Center
🇺🇸La Jolla, California, United States
Pacific Sleep Medicine
🇺🇸Oceanside, California, United States
Stanford University Center for Narcolepsy
🇺🇸Redwood City, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Clinical Research Group of St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
Florida Pediatric Research Institute
🇺🇸Winter Park, Florida, United States
SleepMed of Central Georgia
🇺🇸Macon, Georgia, United States
NeuroTrials Research Inc.
🇺🇸Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago College of Nursing
🇺🇸Chicago, Illinois, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
The Center for Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Clinical Neurophysiology Services
🇺🇸Sterling Heights, Michigan, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
Sleep Medicine & Research Center, St. Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Minnesota Lung Center
🇺🇸Edina, Minnesota, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Hickory Research Center, ARSM Research, LLC
🇺🇸Huntersville, North Carolina, United States
Clinilabs
🇺🇸New York, New York, United States
Hickory Research Center
🇺🇸Hickory, North Carolina, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Northcoast Clinical Trials Inc.
🇺🇸Beachwood, Ohio, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Ohio Sleep Medicine & Neuroscience Institute
🇺🇸Dublin, Ohio, United States
Sleep Med of South Carolina
🇺🇸Columbia, South Carolina, United States
FutureSearch Trials of Neurology LP
🇺🇸Austin, Texas, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Niagra Clinical Research
🇨🇦Niagra Falls, Ontario, Canada
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Toronto Sleep Institute
🇨🇦Toronto, Ontario, Canada
Toronto Psychiatric Research Foundation
🇨🇦Toronto, Ontario, Canada
Hospital Roger Salengro
🇫🇷Lille, France
Pediatric Sleep Research Inc.
🇨🇦Toronto, Ontario, Canada
Universite Paris 5 Hôtel-Dieu
🇫🇷Paris, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
🇩🇪Regensburg, Bayern, Germany
Advanced Sleep Research GmbH
🇩🇪Berlin, Germany
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
🇩🇪Schwerin, Germany
Sleep Wake Center SEIN Heemstede
🇳🇱Heemsteded, Noord Holland, Netherlands
Universitätsklinikum Münster Department für Neurologie
🇩🇪Muenster, North Rhine-Westphalia, Germany
Pacific Research Network, Inc.
🇺🇸San Diego, California, United States
Henry Ford Hospital Sleep Disorders & Research Center
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Sleep Management Institute
🇺🇸Cincinnati, Ohio, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States
Studienzentrum Wilhelmshoehe
🇩🇪Kassel, Germany
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
🇺🇸Toledo, Ohio, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States