A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD
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)
Axsome Therapeutics, Inc.
468 participants
Jul 6, 2026
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 children aged 6 to \<12 years with ADHD.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
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Interventions
Solriamfetol capsules, taken once daily
Solriamfetol capsules, taken once daily
Placebo capsules, taken once daily
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07717879