Trials / Completed
CompletedNCT04789174
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Axsome Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Solriamfetol | Solriamfetol 75 mg/d Solriamfetol 150 mg/d |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2021-05-17
- Primary completion
- 2022-09-19
- Completion
- 2022-09-19
- First posted
- 2021-03-09
- Last updated
- 2026-01-26
- Results posted
- 2026-01-26
Locations
28 sites across 6 countries: United States, Canada, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04789174. Inclusion in this directory is not an endorsement.