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NCT05972044 Clinical Trial

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 Details — Status: Recruiting

Administrative data
NCT number NCT05972044
Other study ID # SOL-ADHD-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 6, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-5061
Email cstreicher@axsome.com
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
• Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
• Placebo
Placebo tablets, taken once daily

Locations
Country Name City State
United States Clinical Research Site Alpharetta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Bellaire Texas
United States Clinical Research Site Berlin New Jersey
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Cherry Hill New Jersey
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Colorado Springs Colorado
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Draper Utah
United States Clinical Research Site Encino California
United States Clinical Research Site Everett Washington
United States Clinical Research Site Gainesville Florida
United States Clinical Research Site Garden Grove California
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Jacksonville Florida
United States Clinical Research Site Kettering Ohio
United States Clinical Research Site Lafayette California
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Marietta Georgia
United States Clinical Research Site Media Pennsylvania
United States Clinical Research Site Memphis Tennessee
United States Clinical Research Site Miami Lakes Florida
United States Clinical Research Site Mount Kisco New York
United States Clinical Research Site New York New York
United States Clinical Research Site North Charleston South Carolina
United States Clinical Research Site Oklahoma City Oklahoma
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Overland Park Kansas
United States Clinical Research Site Palm Bay Florida
United States Clinical Research Site Raleigh North Carolina
United States Clinical Research Site Riverside California
United States Clinical Research Site Saint Charles Missouri
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site Santa Ana California
United States Clinical Research Site Sherman Oaks California
United States Clinical Research Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline to Week 6 in the AISRS total score Adult ADHD Investigator Symptom Report Scale (AISRS) 6 weeks
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