Phase 3
N=474
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02348606 ↗Enrolled (actual)
474
Serious AEs
1.1%
Results posted
Jul 2019
Primary outcome: Primary: Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 — 4.74; 9.08; 10.96; 12.99 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- JZP-110 (Drug); Placebo oral tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 |
4.74; 9.08; 10.96; 12.99; 0.21 | — |
| PRIMARY Change in ESS Score From Baseline to Week 12 |
-5.1; -5.0; -7.7; -7.9; -3.3 | — |
| SECONDARY Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 |
55.4; 72.4; 89.7; 88.7; 49.1 | — |
| SECONDARY Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 |
3.03; 5.77; 10.87; 12.48; -0.40; 6.93 | — |
| 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 |
4.53; 7.20; 11.69; 13.77; 1.24 | — |
| SECONDARY Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 |
-4.5; -4.4; -5.5; -6.6; -2.6; -4.7 | — |
| SECONDARY Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 |
58.9; 65.5; 78.3; 82.5; 47.4; 60.7 | — |
| SECONDARY Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 |
58.9; 70.7; 90.5; 88.7; 49.1 | — |
| SECONDARY Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 |
62.5; 60.3; 75.7; 82.6; 46.5; 60.7 | — |
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.
Eligibility Criteria
Major 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
Major 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the 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
- 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
Data sourced from ClinicalTrials.gov (NCT02348606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.