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NCT07717879PHASE3Recruiting

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)

Axsome Therapeutics, Inc.

Start Date

7/6/2026

Completion Date

6/30/2028

Summary

This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to \<12 years with ADHD.

Detailed Description

Eligible subjects are children, 6 to \<12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.

Eligibility Criteria

Age Range: 6 years to 11 years

Inclusion Criteria: * Male or female, aged 6 to \<12 years. * Primary diagnosis of ADHD according to DSM-5 criteria. * Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Interventions

DRUG

Solriamfetol Dose A

DRUG

Solriamfetol Dose B

DRUG

Placebo

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Conditions

ADHD

Locations

Clinical Research Site

Dothan, Alabama 36303

United States

Clinical Research Site

Little Rock, Arkansas 72211

United States

Clinical Research Site

Anaheim, California 92805

United States

Clinical Research Site

Irvine, California 92604

United States

Clinical Research Site

Long Beach, California 90806

United States

Clinical Research Site

Orange, California 92868

United States

Clinical Research Site

Walnut Creek, California 94596

United States

Clinical Research Site

Coral Gables, Florida 33146

United States

Clinical Research Site

Gainesville, Florida 32607

United States

Clinical Research Site

Jacksonville, Florida 32256

United States

Clinical Research Site

Maitland, Florida 32751

United States

Clinical Research Site

Orlando, Florida 32801

United States

Clinical Research Site

Orlando, Florida 32803

United States

Clinical Research Site

Atlanta, Georgia 30318

United States

Clinical Research Site

Bardstown, Kentucky 40004

United States

Clinical Research Site

Owensboro, Kentucky 42301

United States

Clinical Research Site

Springfield, Massachusetts 01103

United States

Clinical Research Site

Worcester, Massachusetts 01608

United States

Clinical Research Site

Jackson, Mississippi 39206

United States

Clinical Research Site

Las Vegas, Nevada 89128

United States

Clinical Research Site

Staten Island, New York 10314

United States

Clinical Research Site

Portland, Oregon 97210

United States

Clinical Research Site

North Charleston, South Carolina 29405

United States

Clinical Research Site

Memphis, Tennessee 38119

United States

Clinical Research Site

Austin, Texas 78759

United States

Clinical Research Site

Friendswood, Texas 77546

United States

Clinical Research Site

San Antonio, Texas 78229

United States

Clinical Research Site

Provo, Utah 84604

United States

Clinical Research Site

Petersburg, Virginia 23805

United States

Clinical Research Site

Everett, Washington 98201

United States