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

NCT ID: NCT07717879
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Axsome Therapeutics, Inc.
Conditions: ADHD

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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)

Enrollment: 468 participants (Estimated).

What is being studied

Drug: Placebo
Drug: Solriamfetol Dose A
Drug: Solriamfetol Dose B

Who may be eligible

Ages: 6 Years to 11 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

23 study locations are listed.

Recruiting site status is explicitly provided for 23 locations; 23 are listed as Recruiting.

Countries: United States

Alabama, United States: 1
Arkansas, United States: 1
California, United States: 4
Florida, United States: 4
Georgia, United States: 1
Kentucky, United States: 1
Massachusetts, United States: 2
Mississippi, United States: 1
Nevada, United States: 1
New York, United States: 1
South Carolina, United States: 1
Tennessee, United States: 1
Texas, United States: 3
Utah, United States: 1

Sample of listed locations

Clinical Research Site — Dothan, Alabama, 36303, United States — Recruiting
Clinical Research Site — Little Rock, Arkansas, 72211, United States — Recruiting
Clinical Research Site — Irvine, California, 92604, United States — Recruiting
Clinical Research Site — Long Beach, California, 90806, United States — Recruiting
Clinical Research Site — Orange, California, 92868, United States — Recruiting
Clinical Research Site — Walnut Creek, California, 94596, United States — Recruiting
Clinical Research Site — Coral Gables, Florida, 33146, United States — Recruiting
Clinical Research Site — Jacksonville, Florida, 32256, United States — Recruiting
Clinical Research Site — Maitland, Florida, 32751, United States — Recruiting
Clinical Research Site — Orlando, Florida, 32801, United States — Recruiting
Clinical Research Site — Atlanta, Georgia, 30318, United States — Recruiting
Clinical Research Site — Bardstown, Kentucky, 40004, United States — Recruiting
Clinical Research Site — Springfield, Massachusetts, 01103, United States — Recruiting
Clinical Research Site — Worcester, Massachusetts, 01608, United States — Recruiting
Clinical Research Site — Jackson, Mississippi, 39206, United States — Recruiting
Clinical Research Site — Las Vegas, Nevada, 89128, United States — Recruiting
Clinical Research Site — Staten Island, New York, 10314, United States — Recruiting
Clinical Research Site — North Charleston, South Carolina, 29405, United States — Recruiting
Clinical Research Site — Memphis, Tennessee, 38119, United States — Recruiting
Clinical Research Site — Austin, Texas, 78759, United States — Recruiting
Clinical Research Site — Friendswood, Texas, 77546, United States — Recruiting
Clinical Research Site — San Antonio, Texas, 78229, United States — Recruiting
Clinical Research Site — Provo, Utah, 84604, United States — Recruiting

Study details

Start date: July 6, 2026
Primary completion date: June 30, 2028
Completion date: June 30, 2028
First posted: July 21, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07717879
Registry last updated: September 8, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07717879 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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