Obstructive sleep apnea
Conditions
Interventions
7 days of JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days)
and 7 days of placebo in counterbalanced order
Sponsors
JAZZ Pharmaceuticals Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female, age 21 to 75 years inclusive - Diagnosis of obstructive sleep apnea (OSA) per ICSD-3 criteria - BMI 18 to
Exclusion criteria
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 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 and/or safety assessments per the judgment of the investigator - History of bariatric surgery within the past year - Presence of significant cardiovascular disease - Use of any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard deviation of lateral position (SDLP) at 2 hours post-dose (approximately at Tmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| * SDLP at 6 hr post-dose * Proportion of subjects with improved or impaired driving on JZP-110 compared to placebo * Standard deviation of Speed (SDS) * Driving lapses * PVT measures * Inverse reaction time (1/RT) * Lapses (RT>500 ms) * Mean reaction time (RT) * Errors of commission * Toronto Hospital Alertness Test (THAT) | — |
Countries
Netherlands
Outcome results
None listed