CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Solriamfetol +1 moredrug
Likely dose
Solriamfetol 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04789174
NCT04789174Phase 4Completed

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

Axsome Therapeutics, Inc.·interventional·Posted Mar 9, 2021·Updated Jan 26, 2026

In Brief

A Phase 4 clinical trial evaluating Solriamfetol and Placebo for Excessive Daytime Sleepiness and 2 related conditions. Completed, enrolled 59 participants across 28 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 9, 2021
Enrollment StartMay 17, 2021
Primary CompletionSep 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

Solriamfetoldrug

Solriamfetol 75 mg/d Solriamfetol 150 mg/d

Placebodrug

Placebo