Status:
COMPLETED
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
Lead Sponsor:
Axsome Therapeutics, Inc.
Conditions:
ADHD
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the effica...
Detailed Description
Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio ...
Eligibility Criteria
Inclusion
- Primary diagnosis of ADHD according to DSM-5 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
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2025
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT05972044
Start Date
July 6 2023
End Date
March 14 2025
Last Update
April 3 2025
Active Locations (42)
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1
Clinical Research Site
Encino, California, United States, 91316
2
Clinical Research Site
Garden Grove, California, United States, 92845
3
Clinical Research Site
Newport Beach, California, United States, 92660
4
Clinical Research Site
Riverside, California, United States, 92506