RecruitingPhase 3NCT07717892

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)

A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)


Sponsor

Axsome Therapeutics, Inc.

Enrollment

468 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

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 adolescents aged 12 to \<18 years with ADHD.


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called Solriamfetol Dose A, and others for people with adhd. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 12 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSolriamfetol Dose A

Solriamfetol capsules, taken once daily

DRUGSolriamfetol Dose B

Solriamfetol capsules, taken once daily

DRUGPlacebo

Placebo capsules, taken once daily


Locations(24)

Clinical Research Site

Dothan, Alabama, United States

Clinical Research Site

Little Rock, Arkansas, United States

Clinical Research Site

Irvine, California, United States

Clinical Research Site

Long Beach, California, United States

Clinical Research Site

Los Angeles, California, United States

Clinical Research Site

Walnut Creek, California, United States

Clinical Research Site

Coral Gables, Florida, United States

Clinical Research Site

Gainesville, Florida, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Maitland, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Atlanta, Georgia, United States

Clinical Research Site

Bardstown, Kentucky, United States

Clinical Research Site

Springfield, Massachusetts, United States

Clinical Research Site

Worcester, Massachusetts, United States

Clinical Research Site

Jackson, Mississippi, United States

Clinical Research Site

Las Vegas, Nevada, United States

Clinical Research Site

Staten Island, New York, United States

Clinical Research Site

North Charleston, South Carolina, United States

Clinical Research Site

Memphis, Tennessee, United States

Clinical Research Site

Austin, Texas, United States

Clinical Research Site

Friendswood, Texas, United States

Clinical Research Site

San Antonio, Texas, United States

Clinical Research Site

Provo, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07717892


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