"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
- Registration Number
- NCT02348593
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
- Males and females between 18 and 75 years of age, inclusive
- Diagnosis of narcolepsy according to ICSD-3 or DSM-5 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
- Moderate or severe sleep apnea on the baseline PSG.
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy 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 gastic 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
- Use of any medications that could affect the evaluation of cataplexy
- Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, 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 150 mg JZP-110 JZP-110 Once Daily Dosing 300 mg of JZP-110 JZP-110 Once Daily Dosing Placebo Placebo oral tablet Once Daily Dosing 75 mg of JZP-110 JZP-110 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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
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 Baseline to Week 12 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 treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
Change in Sleep Latency Time on MWT Trial 1 at Week 12 Change from baseline for sleep latency in MWT during trial 1 at 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 Sleep Latency Time on MWT Trial 2 at Week 12 Change from baseline for sleep latency in MWT during trial 2 at 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 Sleep Latency Time on MWT Trial 3 at Week 12 Change from baseline for sleep latency in MWT during trial 3 at 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 Sleep Latency Time on MWT Trial 4 at Week 12 Change from baseline for sleep latency in MWT during trial 4 at 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 Sleep Latency Time on MWT Trial 5 at Week 12 Change from baseline for sleep latency in MWT during trial 5 at 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.
Trial Locations
- Locations (59)
Pediatric Sleep Research Inc.
🇨🇦Toronto, Ontario, Canada
Stanford University Center for Narcolepsy
🇺🇸Redwood City, California, United States
Sleep Med of South Carolina
🇺🇸Columbia, South Carolina, United States
NeuroTrials
🇺🇸Atlanta, Georgia, United States
Northwestern University, Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Illinois Chicago, College of Nursing
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
SleepMed of Central Georgia
🇺🇸Macon, Georgia, United States
So Cal Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
SDS Clinical Trials
🇺🇸Orange, California, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Emory Sleep Center
🇺🇸Atlanta, Georgia, United States
Minnesota Lung Center
🇺🇸Edina, Minnesota, United States
Clinical Neurophysiology Services
🇺🇸Sterling Heights, Michigan, United States
FutureSearch Trials of Neurology LP
🇺🇸Austin, Texas, United States
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
🇩🇪Regensburg, Bayern, Germany
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Toronto Sleep Institute
🇨🇦Toronto, Ontario, Canada
Todd J. Swick
🇺🇸Houston, Texas, United States
Hospital Roger Salengro
🇫🇷Lille, France
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
🇩🇪Schwerin, Germany
Universite Paris 5 Hôtel-Dieu
🇫🇷Paris, France
Hickory Research Center, ARSM Research, LLC
🇺🇸Huntersville, North Carolina, United States
Helsinki Sleep Clinic
🇫🇮Helsinki, Finland
Studienzentrum Wilhelmshoehe
🇩🇪Kassel, Germany
Advanced Sleep Research GmbH
🇩🇪Berlin, Germany
Pacific Research Network, Inc.
🇺🇸San Diego, California, United States
Sleep Management Institute
🇺🇸Cincinnati, Ohio, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Universitaetsklinikum Muenster
🇩🇪Muenster, North Rhine-Westphalia, Germany
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States
Hickory Research Center
🇺🇸Hickory, North Carolina, United States
Pulmonary Associates
🇺🇸Glendale, Arizona, United States
Pacific Sleep Medicine
🇺🇸Oceanside, California, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Critical Care Pulmonary & Sleep Associates, LLC
🇺🇸Lakewood, Colorado, United States
Florida Pediatric Research Institute
🇺🇸Winter Park, Florida, United States
Clinical Research Group of St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
The Center for Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Veritas Clinical Specialties LTD
🇺🇸Topeka, Kansas, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
New York University Medical center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Ohio Sleep Medicine & Neuroscience Institute
🇺🇸Dublin, Ohio, United States
Lowcountry Lung Critical Care
🇺🇸Charleston, South Carolina, United States
CARSM Sleep Laboratory & Clinic
🇨🇦Montreal, Quebec, Canada
Sleep Wake Center SEIN Heemstede
🇳🇱Heemstede, Noord Holland, Netherlands
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
🇺🇸Toledo, Ohio, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Toronto Psychiatric Research Foundation
🇨🇦Toronto, Ontario, Canada
North Coast Clinical Trials Inc.
🇺🇸Beachwood, Ohio, United States
Southwest Cleveland Sleep Research Center
🇺🇸Cleveland, Ohio, United States
Montefiore Medical center
🇺🇸Bronx, New York, United States