RecruitingPhase 3NCT07717879

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

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

Sponsor

Axsome Therapeutics, Inc.

Enrollment

468 participants

Start Date

Jul 6, 2026

Study Type

INTERVENTIONAL

Conditions

ADHD

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.

Eligibility

Min Age: 6 YearsMax Age: 11 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 6 Years to 11 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSolriamfetol Dose A

Solriamfetol capsules, taken once daily

DRUGSolriamfetol Dose B

Solriamfetol capsules, taken once daily

DRUGPlacebo

Placebo capsules, taken once daily

Locations(23)

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

Orange, California, United States

Clinical Research Site

Walnut Creek, California, United States

Clinical Research Site

Coral Gables, 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

For the most up-to-date information, visit the official listing.

Visit

NCT07717879

Related Trials

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

NCT077178929 locations

Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD

NCT07784348

Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study

NCT07684417

Virtual Reality Attention Management

NCT032212441 location

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

NCT060813487 locations