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Clinical Trials in the USA / NCT07773883
Enrolling by invitation Phase 3

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD

NCT07773883 · tracked via the Priya Life Science USA tracker
Sponsor
Axsome Therapeutics, Inc
Phase
Phase 3
Started
2026-08-06
Last updated
2026-10-13

Condition(s) studied

ADHD

Investigational drug(s) / intervention(s)

Solriamfetol →

Solriamfetol: Solriamfetol capsules, taken once daily

Study summary

This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). * Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Primary outcome measure(s)

  • Treatment-Emergent Adverse Events (TEAEs) — Up to 52 weeks
    An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.

Trial sites (7)

FacilityCityRegionStatus
Clinical Research Site Dothan Alabama
Clinical Research Site Little Rock Arkansas
Clinical Research Site Jacksonville Florida
Clinical Research Site Maitland Florida
Clinical Research Site Orlando Florida
Clinical Research Site North Charleston South Carolina
Clinical Research Site Memphis Tennessee

More Axsome Therapeutics, Inc. trials in the USA

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Recruiting
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) Recruiting
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design Recruiting
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder Enrolling by invitation
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) Recruiting

Other trials for the same condition

A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications Recruiting
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17. Recruiting
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) Recruiting
An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms Active, not recruiting
EndeavorOTC™ Prospective Product Registry Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07773883 on ClinicalTrials.gov ↗ ← All trials in the USA