"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

Obstructive Sleep Apnea Clinical Trial

— OSA  

Official title:

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348606
• Other study ID #: 14-003
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2019
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Major Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive

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

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating

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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the 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

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness

Intervention

Drug:
• JZP-110

• Placebo oral tablet

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Niagra Clinical Research	Niagra Falls	Ontario
Canada	Pediatric Sleep Research Inc.	Toronto	Ontario
Canada	Toronto Psychiatric Research Foundation	Toronto	Ontario
Canada	Toronto Sleep Institute	Toronto	Ontario
France	Hospital Roger Salengro	Lille
France	Hopital Bichat - Claude Bernard	Paris
France	Universite Paris 5 Hôtel-Dieu	Paris
Germany	Advanced Sleep Research GmbH	Berlin
Germany	Studienzentrum Wilhelmshoehe	Kassel
Germany	Universitätsklinikum Münster Department für Neurologie	Muenster	North Rhine-Westphalia
Germany	medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum	Regensburg	Bayern
Germany	Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin
Netherlands	Sleep Wake Center SEIN Heemstede	Heemsteded	Noord Holland
United States	NeuroTrials Research Inc.	Atlanta	Georgia
United States	FutureSearch Trials of Neurology LP	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Northcoast Clinical Trials Inc.	Beachwood	Ohio
United States	PAB Clinical Research	Brandon	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Sleep Medicine & Research Center, St. Luke's Hospital	Chesterfield	Missouri
United States	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	University of Illinois at Chicago College of Nursing	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Sleep Management Institute	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Southwest Cleveland Sleep Research Center	Cleveland	Ohio
United States	Sleep Med of South Carolina	Columbia	South Carolina
United States	University of Missouri	Columbia	Missouri
United States	Henry Ford Hospital Sleep Disorders & Research Center	Detroit	Michigan
United States	Ohio Sleep Medicine & Neuroscience Institute	Dublin	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Minnesota Lung Center	Edina	Minnesota
United States	Pulmonary Associates	Glendale	Arizona
United States	MD Clinical	Hallandale Beach	Florida
United States	Hickory Research Center	Hickory	North Carolina
United States	Todd J. Swick	Houston	Texas
United States	Hickory Research Center, ARSM Research, LLC	Huntersville	North Carolina
United States	UC San Diego Medical Center	La Jolla	California
United States	Preferred Research Partners	Little Rock	Arkansas
United States	So Cal Institute For Respiratory Diseases, Inc.	Los Angeles	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	SleepMed of Central Georgia	Macon	Georgia
United States	Clinilabs	New York	New York
United States	Neurocare, Inc.	Newton	Massachusetts
United States	Pacific Sleep Medicine	Oceanside	California
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Stanford University Center for Narcolepsy	Redwood City	California
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Clinical Research Group of St. Petersburg	Saint Petersburg	Florida
United States	Sleep Therapy & Research Center	San Antonio	Texas
United States	Pacific Research Network, Inc.	San Diego	California
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Clinical Neurophysiology Services	Sterling Heights	Michigan
United States	Mercy St. Anne & Mercy St. Charles Sleep Disorders Center	Toledo	Ohio
United States	Florida Pediatric Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maintenance of Wakefulness Test (MWT) From 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.	Baseline to Week 12
Primary	Change in ESS Score From 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.	Baseline to Week 12
Secondary	Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at 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 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.	12 Weeks
Secondary	Change in Sleep Latency Time on Each of the 5 MWT Trials 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.	Baseline and Week 12
Secondary	Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From 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.	Baseline to Week 4
Secondary	Change in ESS Score From Baseline to Week 1, Week 4, and Week 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.	Baseline to Weeks 1, 4, and 8
Secondary	Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 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.	Weeks 1, 4, and 8
Secondary	Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at 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.	Week 12
Secondary	Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 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.	Weeks 1, 4, and 8