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Central Nervous System Stimulant

Solriamfetol for Obstructive Sleep Apnea (SHARP Trial)

Phase 4
Waitlist Available
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of the second double-blind treatment period (up to study day 37)
Awards & highlights

SHARP Trial Summary

This study is evaluating whether a drug may help improve cognitive function in individuals with excessive daytime sleepiness.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Cognitive Impairment
  • Excessive Daytime Sleepiness

SHARP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the end of the second double-blind treatment period (up to study day 37)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of the second double-blind treatment period (up to study day 37) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from the average of the DSST RBANS scores at Baseline to the average of the postdose DSST RBANS scores at the end of each double-blind treatment period
Secondary outcome measures
Change from baseline to the end of each double-blind treatment period in ESS score
Change from baseline to the end of each double-blind treatment period in overall score in BC-CCI
Change from each of the 2-, 4-, 6-, and 8-hour DSST RBANS sores at Baseline to each of the corresponding 2-, 4-, 6-, and 8-hour postdose DSST RBANS scores at the end of each double-blind treatment period

SHARP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SolriamfetolActive Control1 Intervention
Solriamfetol 75 mg/d Solriamfetol 150 mg/d
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
8,133 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,226 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
2021. "Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789174.
~15 spots leftby Apr 2025
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