A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT07717879

Run by

Axsome Therapeutics, Inc.

People needed

468

Starts

2026-07-06

Expected to finish

2028-06-30

Last updated by the study team

2026-07-21

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.

Where it is running

• Clinical Research Site — Dothan, Alabama, United States (enrolling)
• Clinical Research Site — Little Rock, Arkansas, United States (enrolling)
• Clinical Research Site — Coral Gables, Florida, United States (enrolling)
• Clinical Research Site — Jacksonville, Florida, United States (enrolling)
• Clinical Research Site — Maitland, Florida, United States (enrolling)
• Clinical Research Site — Orlando, Florida, United States (enrolling)
• Clinical Research Site — Bardstown, Kentucky, United States (enrolling)
• Clinical Research Site — Memphis, Tennessee, United States (enrolling)
• Clinical Research Site — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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