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

July 16, 2026 updated by: Axsome Therapeutics, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

468

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Clinical Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Clinical Research Site
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Research Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Research Site
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Recruiting
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Up to 6 weeks
Drug: Placebo
Placebo capsules, taken once daily
Experimental: Solriamfetol Dose A
Up to 6 weeks
Drug: Solriamfetol Dose A
Solriamfetol capsules, taken once daily
Experimental: Solriamfetol Dose B
Up to 6 weeks
Drug: Solriamfetol Dose B
Solriamfetol capsules, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-ADHD-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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