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NCT04789174 · ClinicalTrials.gov registry record · Phase 4
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
A Phase 4 study of Obstructive Sleep Apnea and Excessive Daytime Sleepiness, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT04789174: Completed Phase 4 study of Obstructive Sleep Apnea and Excessive Daytime Sleepiness, sponsored by Axsome Therapeutics.
NCT04789174 is a Phase 4 study of Obstructive Sleep Apnea and Excessive Daytime Sleepiness that has completed, run by Axsome Therapeutics. The registered enrollment target is 59 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789174, a Phase 4 study of Obstructive Sleep Apnea and Excessive Daytime Sleepiness, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The DSST RBANS (Digit Symbol Substitution Test Repeatable Battery for the Assessment of Neuropsychological Status) is an objective neuropsychological test that assesses executive function, processing speed and attention. DSST RBANS scores range from a minimum of 0 (worse outcome) to a maximum of 100 (better outcome). The change from baseline was calculated as post-baseline - baseline. A positive change indicates improvement.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Solriamfetol
Study Locations (20)
California
- Southern California Institute for Respiratory Disease - Los Angeles
- SDS Clinical Trials, Inc - Santa Ana
Georgia
- NeuroTrials Research Inc - Atlanta
- The Neurological Center of north Georgia. - Gainesville
Ohio
- CTI-Clinical Research Center - Cincinnati
- Intrepid Research, LLC - Cincinnati
Texas
- FutureSearch Trials of Neuroglogy - Austin
- Sleep Therapy & Research Center - San Antonio
Ontario
- MedSleep Inc. o/a Toronto Sleep Institute - Toronto
- Jodha Tishon Inc - Toronto
Florida
- Clinical Neuroscience Solutions, Inc - Jacksonville
Maryland
- The Center for Sleep & Wake Disorders - Chevy Chase
Michigan
- Henry Ford Health System - Novi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2022-09-19 |
| Phase | Phase 4 |
What the finished NCT04789174 record still lists
NCT04789174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04789174 names 20 study sites across 15 states, led by California, Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT04789174 about?
NCT04789174 is a clinical study titled "Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study". 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.
What is the current status of trial NCT04789174?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2021-05-17. Estimated completion is 2022-09-19.
What conditions does trial NCT04789174 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Excessive Daytime Sleepiness, Impaired Cognitive Function.
What interventions are being tested in trial NCT04789174?
The interventions under investigation include: Placebo (DRUG), Solriamfetol (DRUG).
Who is sponsoring clinical trial NCT04789174?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04789174 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04789174's enrollment target sits among peer trials
59 97th of 155 higher than 59 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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