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

July 21, 2019 updated by: Jazz Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

476

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Niagra Falls, Ontario, Canada, L2E 7H9
        • Niagra Clinical Research
      • Toronto, Ontario, Canada, M4P 1P2
        • Toronto Sleep Institute
      • Toronto, Ontario, Canada, m5K 2A7
        • Toronto Psychiatric Research Foundation
      • Toronto, Ontario, Canada, M6J 3S3
        • Pediatric Sleep Research Inc.
  • France
      • Lille, France, 59000
        • Hospital Roger Salengro
      • Paris, France, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris, France, 75004
        • Universite Paris 5 Hôtel-Dieu
  • Germany
      • Berlin, Germany, 10117
        • Advanced Sleep Research GmbH
      • Kassel, Germany, 34131
        • Studienzentrum Wilhelmshoehe
      • Schwerin, Germany, 19053
        • Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
    • Bayern
      • Regensburg, Bayern, Germany, 93053
        • medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
    • North Rhine-Westphalia
      • Muenster, North Rhine-Westphalia, Germany, 48149
        • Universitätsklinikum Münster Department für Neurologie
  • Netherlands
    • Noord Holland
      • Heemsteded, Noord Holland, Netherlands, 2103 SW
        • Sleep Wake Center SEIN Heemstede
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Pulmonary Associates
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Medical Center
      • Los Angeles, California, United States, 90048
        • So Cal Institute For Respiratory Diseases, Inc.
      • Oceanside, California, United States, 92054
        • Pacific Sleep Medicine
      • Redwood City, California, United States, 94063
        • Stanford University Center for Narcolepsy
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc.
    • Florida
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Saint Petersburg, Florida, United States, 33707
        • Clinical Research Group of St. Petersburg
      • Winter Park, Florida, United States, 32789
        • Florida Pediatric Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research Inc.
      • Macon, Georgia, United States, 31201
        • SleepMed of Central Georgia
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago College of Nursing
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Kentucky Research Group
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Hospital
      • Chevy Chase, Maryland, United States, 20815
        • The Center for Sleep & Wake Disorders
    • Massachusetts
      • Newton, Massachusetts, United States, 24590
        • Neurocare, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Sleep Disorders & Research Center
      • Sterling Heights, Michigan, United States, 48314
        • Clinical Neurophysiology Services
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Minnesota Lung Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Sleep Medicine & Research Center, St. Luke's Hospital
      • Columbia, Missouri, United States, 65201
        • University of Missouri
      • Saint Louis, Missouri, United States, 63143
        • Clayton Sleep Institute
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10019
        • Clinilabs
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Hickory, North Carolina, United States, 28602
        • Hickory Research Center
      • Huntersville, North Carolina, United States, 28078
        • Hickory Research Center, ARSM Research, LLC
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • NorthCoast Clinical Trials Inc.
      • Cincinnati, Ohio, United States, 45245
        • Sleep Management Institute
      • Cincinnati, Ohio, United States, 45255
        • CTI Clinical Research Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44130
        • Southwest Cleveland Sleep Research Center
      • Dublin, Ohio, United States, 43017
        • Ohio Sleep Medicine & Neuroscience Institute
      • Toledo, Ohio, United States, 43606
        • Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Sleep Med of South Carolina
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology LP
      • Houston, Texas, United States, 77063
        • Todd J. Swick
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy & Research Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 37.5 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 75 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 150 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 300 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: Placebo
Once Daily Dosing
Drug: Placebo oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Time Frame: 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
Change in ESS Score From Baseline to Week 12
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Time Frame: 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.
12 Weeks
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Time Frame: 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.
Baseline and 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
Time Frame: 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
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
Time Frame: 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.
Baseline to Weeks 1, 4, and 8
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Time Frame: 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.
Weeks 1, 4, and 8
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
Time Frame: 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
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Time Frame: 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.
Weeks 1, 4, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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