A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
NCT ID: NCT05972044
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
516 participants
INTERVENTIONAL
2023-07-06
2025-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Solriamfetol 150 mg
Up to 6 weeks
Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Solriamfetol 300 mg
Up to 6 weeks
Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo
Up to 6 weeks
Placebo
Placebo tablets, taken once daily
Interventions
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Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo
Placebo tablets, taken once daily
Eligibility Criteria
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Inclusion Criteria
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 55 inclusive.
Exclusion Criteria
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
18 Years
55 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Encino, California, United States
Clinical Research Site
Garden Grove, California, United States
Clinical Research Site
Newport Beach, California, United States
Clinical Research Site
Riverside, California, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Sherman Oaks, California, United States
Clinical Research Site
Torrance, California, United States
Clinical Research Site
Walnut Creek, California, United States
Clinical Research Site
Colorado Springs, Colorado, United States
Clinical Research Site
Clermont, Florida, United States
Clinical Research Site
Doral, Florida, United States
Clinical Research Site
Gainesville, Florida, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Lauderhill, Florida, United States
Clinical Research Site
Miami Lakes, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Marietta, Georgia, United States
Clinical Research Site
Overland Park, Kansas, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Saint Charles, Missouri, United States
Clinical Research Site
Lincoln, Nebraska, United States
Clinical Research Site
Las Vegas, Nevada, United States
Clinical Research Site
Las Vegas, Nevada, United States
Clinical Research Site
Berlin, New Jersey, United States
Clinical Research Site
Cherry Hill, New Jersey, United States
Clinical Research Site
Princeton, New Jersey, United States
Clinical Research Site
Mount Kisco, New York, United States
Clinical Research Site
New York, New York, United States
Clinical Research Site
Raleigh, North Carolina, United States
Clinical Research Site
Cincinnati, Ohio, United States
Clinical Research Site
Kettering, Ohio, United States
Clinical Research Site
Oklahoma City, Oklahoma, United States
Clinical Research Site
Media, Pennsylvania, United States
Clinical Research Site
North Charleston, South Carolina, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
Austin, Texas, United States
Clinical Research Site
Bellaire, Texas, United States
Clinical Research Site
Dallas, Texas, United States
Clinical Research Site
Dallas, Texas, United States
Clinical Research Site
San Antonio, Texas, United States
Clinical Research Site
Draper, Utah, United States
Clinical Research Site
Everett, Washington, United States
Countries
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Related Links
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Axsome Therapeutics Website
Other Identifiers
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SOL-ADHD-301
Identifier Type: -
Identifier Source: org_study_id
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