A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, 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)
Overview
- Phase
- Phase 3
- Intervention
- JZP-110
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 174
- Locations
- 30
- Primary Endpoint
- Change in the Maintenance of Wakefulness Test (MWT)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female between 18 and 75 years of age, inclusive
- •Diagnosis of OSA according to ICSD-3 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
Exclusion Criteria
- •Female subjects who are pregnant, nursing, or lactating.
- •Any other clinically relevant medical, behavioral, or psychiatric disorder other than 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
- •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 or safety assessments or the ability of the subject to complete the trial per the judgment of the principal investigator
- •History of bariatric surgery within the past year or a history of any gastric 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
- •Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- •Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
- •History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Arms & Interventions
75, 150, 300 mg of JZP-110
Once Daily Dosing
Intervention: JZP-110
Placebo
Once Daily Dosing
Intervention: JZP-110
Outcomes
Primary Outcomes
Change in the Maintenance of Wakefulness Test (MWT)
Time Frame: Week 4 to Week 6
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Change in the Epworth Sleepiness Scale (ESS)
Time Frame: Week 4 to Week 6
Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6.
Secondary Outcomes
- Patient Global Impression of Change (PGIc)(Week 4 to Week 6)
- Clinical Global Impression of Change (CGIc)(Week 4 to Week 6)
- Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)(Week 4 to Week 6)