Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatment jzp-110
Phase phase 3
Sponsor Jazz Pharmaceuticals
Start date May 2015
End date September 2016
Trial size 440 participants
Trial identifier NCT02348606, 14-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Once Daily Dosing
jzp-110
(Active Comparator)
Once Daily Dosing
jzp-110
(Active Comparator)
Once Daily Dosing
jzp-110
(Active Comparator)
Once Daily Dosing
jzp-110
(Active Comparator)
Once Daily Dosing
jzp-110

Primary Outcomes

Measure
Maintenance of Wakefulness Test (MWT): Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 12
time frame: 12 Weeks
Epworth Sleepiness Scale (ESS): Change in ESS score from Baseline to Week 12
time frame: 12 Weeks

Secondary Outcomes

Measure
Patient Global Impression of change: Percentage of subjects reported as improved (minimally, much, or very much) at Week 12
time frame: 12 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Jazz Pharmaceuticals.