Clinical trial Recruiting at 31 sites Phase 3 Interventional Ages 12 to 17

Solriamfetol for ADHD in teens: see if it helps with focus

Official title: A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Run by Axsome Therapeutics, Inc. · NCT07717892 · Data updated 2026-11-12

This phase 3 study tests solriamfetol versus placebo in adolescents with ADHD to see if the medication improves symptoms over 6 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Ages12 Years to 17 Years
SexAll
Enrollment468 (estimated)
SponsorAxsome Therapeutics, Inc.
Industry-sponsored
Locations31 sites (Dothan, Alabama and 30 other locations)
StatusRecruiting
StartedJune 25, 2026
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedNovember 6, 2026
Trial IDNCT07717892 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents aged 12 to under 18 with a DSM-5 ADHD diagnosis and able to complete study procedures.

Probably not a fit

Patients who do not respond to solriamfetol or who experience intolerable side effects may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, and placebo-controlled trial in adolescents aged 12 to under 18 with ADHD. Participants are assigned to solriamfetol at one of two doses or placebo for 6 weeks. The study uses a parallel-group design to compare efficacy and safety across groups. Enrollment requires DSM-5–based ADHD diagnosis and parental consent with child assent. Locations include sites in Dothan, AL; Little Rock, AR; and Anaheim, CA, sponsored by Axsome Therapeutics.

Why it matters

Potential benefit: If successful, participants may experience improved attention and daily functioning from solriamfetol.

How similar studies have gone: Previous ADHD-focused research with solriamfetol for other age groups supports feasibility, though pediatric results are exploratory and require confirmation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male or female, aged 12 to \<18 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.

Where it's running

  • Clinical Research Site
    Dothan, Alabama, United States
    Recruiting
  • Clinical Research Site
    Little Rock, Arkansas, United States
    Recruiting
  • Clinical Research Site
    Anaheim, California, United States
    Recruiting
  • Clinical Research Site
    Irvine, California, United States
    Recruiting
  • Clinical Research Site
    Long Beach, California, United States
    Recruiting
  • Clinical Research Site
    Los Angeles, California, United States
    Recruiting
Show 25 more locations
  • Clinical Research Site
    Walnut Creek, California, United States
    Recruiting
  • Clinical Research Site
    Coral Gables, Florida, United States
    Recruiting
  • Clinical Research Site
    Gainesville, Florida, United States
    Recruiting
  • Clinical Research Site
    Jacksonville, Florida, United States
    Recruiting
  • Clinical Research Site
    Maitland, Florida, United States
    Recruiting
  • Clinical Research Site
    Orlando, Florida, United States
    Recruiting
  • Clinical Research Site
    Orlando, Florida, United States
    Recruiting
  • Clinical Research Site
    Atlanta, Georgia, United States
    Recruiting
  • Clinical Research Site
    Bardstown, Kentucky, United States
    Recruiting
  • Clinical Research Site
    Owensboro, Kentucky, United States
    Recruiting
  • Clinical Research Site
    Springfield, Massachusetts, United States
    Recruiting
  • Clinical Research Site
    Worcester, Massachusetts, United States
    Recruiting
  • Clinical Research Site
    Jackson, Mississippi, United States
    Recruiting
  • Clinical Research Site
    Las Vegas, Nevada, United States
    Recruiting
  • Clinical Research Site
    Staten Island, New York, United States
    Recruiting
  • Clinical Research Site
    Portland, Oregon, United States
    Recruiting
  • Clinical Research Site
    North Charleston, South Carolina, United States
    Recruiting
  • Clinical Research Site
    Memphis, Tennessee, United States
    Recruiting
  • Clinical Research Site
    Austin, Texas, United States
    Recruiting
  • Clinical Research Site
    Friendswood, Texas, United States
    Recruiting
  • Clinical Research Site
    San Antonio, Texas, United States
    Recruiting
  • Clinical Research Site
    Provo, Utah, United States
    Recruiting
  • Clinical Research Site
    Fairfax, Virginia, United States
    Recruiting
  • Clinical Research Site
    Petersburg, Virginia, United States
    Recruiting
  • Clinical Research Site
    Everett, Washington, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.