Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT04789174
Phase
PHASE4
Status
Completed

Conditions

  • Excessive Daytime Sleepiness
  • Impaired Cognitive Function
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Solriamfetol — DRUG
    Solriamfetol 75 mg/d Solriamfetol 150 mg/d
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
May 17, 2021
Status verified
Jan 2026
Primary completion
Sep 19, 2022
Completion
Sep 19, 2022

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Solriamfetol
    Solriamfetol 75 mg/d Solriamfetol 150 mg/d
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period [ Time Frame: Baseline to the end of the second double-blind treatment period (up to 5 weeks) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Southern California Institute for Respiratory DiseaseLos AngelesCalifornia90048-
SDS Clinical Trials, IncSanta AnaCalifornia92705-
Clinical Neuroscience Solutions, IncJacksonvilleFlorida32256-
NeuroTrials Research IncAtlantaGeorgia30328-
The Neurological Center of north Georgia.GainesvilleGeorgia30501-
The Center for Sleep & Wake DisordersChevy ChaseMaryland20815-
Henry Ford Health SystemNoviMichigan48377-
Sleep Medicine & Research CenterChesterfieldMissouri63017-
Advanced Respiratory and Sleep Medicine, PLLCHuntersvilleNorth Carolina28078-
CTI-Clinical Research CenterCincinnatiOhio45212-
Intrepid Research, LLCCincinnatiOhio45245-
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201-
FutureSearch Trials of NeuroglogyAustinTexas78731-
Sleep Therapy & Research CenterSan AntonioTexas78229-
Sleep and Performance Research CenterSpokaneWashington99202-

Find similar trials in Los Angeles, CA

By research site
Southern California Institute for Respiratory Disease· Los Angeles, CASDS Clinical Trials, Inc· Santa Ana, CAClinical Neuroscience Solutions, Inc· Jacksonville, FLNeuroTrials Research Inc· Atlanta, GAThe Neurological Center of north Georgia.· Gainesville, GAThe Center for Sleep & Wake Disorders· Chevy Chase, MD

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