Phase 3
Completed N=174
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Source: ClinicalTrials.gov NCT02348619 ↗Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Change in the Maintenance of Wakefulness Test (MWT) — -0.96; -12.11 minutes
◆ Published Evidence
Established
81citations · ~12 / year
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
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.
Linked Publications
-
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Maintenance of Wakefulness Test (MWT) |
-0.96; -12.11 | — |
| PRIMARY Change in the Epworth Sleepiness Scale (ESS) |
-0.1; 4.5 | — |
| SECONDARY Patient Global Impression of Change (PGIc) |
20; 50 | — |
| SECONDARY Clinical Global Impression of Change (CGIc) |
22; 59 | — |
| SECONDARY Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) |
-0.15; -1.31 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02348619) and the linked publication. 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. Informational only — not medical advice.