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

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.

Enrolling by invitation

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Dothan, Alabama, United States

About this study

Eligible subjects are children and adolescents with ADHD who have completed either Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). Subjects will be assigned to age-based cohorts and will receive solriamfetol once daily for up to 52 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Solriamfetol

Drug

Solriamfetol capsules, taken once daily

Primary outcomes

Treatment-Emergent Adverse Events (TEAEs)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Enrolling by invitation