Solriamfetol for children with ADHD: a 6-week comparison to placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, multi-center, randomized, double-blind study in children with ADHD, designed to compare two doses of solriamfetol to placebo over 6 weeks. Participants are randomly assigned in a 1:1:1 ratio to receive either dose A, dose B, or placebo once daily. The study evaluates safety and efficacy using DSM-5 ADHD criteria and standardized assessments while monitoring for adverse events. Sites include centers in Alabama, Arkansas, and California. Parental consent and child assent are required prior to any study procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Site
  Dothan, Alabama, United States Recruiting
• Clinical Research Site
  Little Rock, Arkansas, United States Recruiting
• Clinical Research Site
  Anaheim, California, United States Recruiting
• Clinical Research Site
  Irvine, California, United States Recruiting
• Clinical Research Site
  Long Beach, California, United States Recruiting
• Clinical Research Site
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: sol-adhd-302@axsome.com
• Phone: 212-332-5061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.