A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
ClinicalTrials.gov ID: NCT05972044
Sponsor: Axsome Therapeutics, Inc.
Information provided by: Axsome Therapeutics, Inc. (Responsible Party)
Last Update Posted: 2023-09-22
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 efficacy and safety of solriamfetol in adults with ADHD.
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 to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults
Intervention / Treatment:
- Drug: Solriamfetol 150 mg
- Drug: Solriamfetol 300 mg
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-07-06 |
| Primary Completion (Estimated) | 2024-12 |
| Study Completion (Estimated) | 2024-12 |
| Enrollment (Estimated) | 450 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
SOL-ADHD-301 |