"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
- Registration Number
- NCT02348632
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 645
-
Subject meets one of the following:
- Completed Study 14-002 or 14-003 (Group A)
- Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
-
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 narcolepsy or 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
- 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
- History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 75 mg - 300 mg of JZP-110 JZP-110 Once Daily Dosing
- Primary Outcome Measures
Name Time Method Change in Epworth Sleepiness Scale (ESS) Score Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks) Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. 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. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.
- Secondary Outcome Measures
Name Time Method Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.
Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.
Trial Locations
- Locations (80)
Center for Sleep and Circadian Neurobiology
🇺🇸Philadelphia, Pennsylvania, United States
Ohio Sleep Medicine & Neuroscience Institute
🇺🇸Dublin, Ohio, United States
UPMC Sleep Medicine Center
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Critical care Pulmonary & Sleep Associates, LLC
🇺🇸Lakewood, Colorado, United States
CARSM Sleep Laboratory & Clinic
🇨🇦Montreal, Quebec, Canada
Sleep Med of South Carolina Clinical Research Solutions
🇺🇸Columbia, South Carolina, United States
Advanced Neurodiagnostic Center
🇺🇸Metairie, Louisiana, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
Veritas Clinical Specialties LTD
🇺🇸Topeka, Kansas, United States
Pacific Sleep Medicine
🇺🇸Oceanside, California, United States
The Research Center of Southern California
🇺🇸Oceanside, California, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Pacific Research Network Inc.
🇺🇸San Diego, California, United States
UC San Diego Medical Center
🇺🇸La Jolla, California, United States
So Cal Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Minnesota Lung Center
🇺🇸Edina, Minnesota, United States
Florida Pediatric Research Institute
🇺🇸Winter Park, Florida, United States
Sleep Medicine & Research center, St. Lukes Hospital
🇺🇸Chesterfield, Missouri, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Clinical Neurophysiology Services
🇺🇸Sterling Heights, Michigan, United States
Toronto Psychiatric Research Foundation
🇨🇦Toronto, Ontario, Canada
Rowe Neurology Institute RNI - Lenexa
🇺🇸Lenexa, Kansas, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Unesta Research Center
🇫🇮Tampere, Finland
New York University Medical Center
🇺🇸New York, New York, United States
Clinilabs
🇺🇸New York, New York, United States
Sleep Management Institute
🇺🇸Cincinnati, Ohio, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Toronto Sleep Institute
🇨🇦Toronto, Ontario, Canada
University of Turku , Sleep Research Centre
🇫🇮Turku, Finland
Grenoble University Hospital
🇫🇷La Tronche, France
CHU de Poitiers
🇫🇷Poitiers, France
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Pediatric Sleep Research Inc
🇨🇦Toronto, Ontario, Canada
Niagra Clinical Research
🇨🇦Niagra Falls, Ontario, Canada
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
Henry Ford Hospital Sleep Disorders & Research Center
🇺🇸Detroit, Michigan, United States
Stanford University Center for Narcolepsy
🇺🇸Redwood City, California, United States
Santa Monica Clinical Trials
🇺🇸Santa Monica, California, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Clinical Research Group of St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
SleepMed of Central Georgia
🇺🇸Macon, Georgia, United States
Emory Sleep Center
🇺🇸Atlanta, Georgia, United States
NeuroTrials Research Inc.
🇺🇸Atlanta, Georgia, United States
Hickory Research Center, ARSM Research, LLC
🇺🇸Huntersville, North Carolina, United States
Todd J. Swick
🇺🇸Houston, Texas, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Hickory Research Center
🇺🇸Hickory, North Carolina, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Pulmonary Associates
🇺🇸Glendale, Arizona, United States
University of Illinois at Chicago Nursing School
🇺🇸Chicago, Illinois, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Northcoast Clinical Trials Inc.
🇺🇸Beachwood, Ohio, United States
Southwest Cleveland Sleep Research Center
🇺🇸Cleveland, Ohio, United States
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
🇺🇸Toledo, Ohio, United States
American Sleep Medicine
🇺🇸Vienna, Virginia, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Hospital Roger Salengro
🇫🇷Lille, France
Universite Paris 5 Hôtel-Dieu
🇫🇷Paris, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
CHU de Dijon
🇫🇷Dijon, France
Sleep Wake Center SEIN Heemstede
🇳🇱Heemstede, Noord Holland, Netherlands
Somnolab Dortmund
🇩🇪Dortmund, Germany
The Center for Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Lowcountry Lung Critical Care
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
FutureSearch Trials of Neurology LP
🇺🇸Austin, Texas, United States
EVMS Sleep Medicine
🇺🇸Norfolk, Virginia, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States