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NCT Number: NCT07717879

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

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.

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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–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Dothan, Alabama, United States

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About this study

Eligible subjects are children, 6 to <12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Solriamfetol Dose A

Drug

Solriamfetol capsules, taken once daily

Solriamfetol Dose B

Drug

Solriamfetol capsules, taken once daily

Placebo

Drug

Placebo capsules, taken once daily

Primary outcomes

  1. ADHD-RS-5 Total Score, Change from Baseline to Week 6

    Time frame: 6 weeks

    Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

929-618-4421

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 21, 2026
Registry last updated
Jul 21, 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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