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A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

ADHD Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05972044
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-5061
Email cstreicher@axsome.com
Status Recruiting
Phase Phase 3
Start date July 6, 2023
Completion date December 2024
View Details
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