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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 468 (estimated) |
| Sponsor | Axsome Therapeutics, Inc. Industry-sponsored |
| Locations | 31 sites (Dothan, Alabama and 30 other locations) |
| Status | Recruiting |
| Started | June 25, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07717892 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
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Dothan, Alabama, United States Recruiting -
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Little Rock, Arkansas, United States Recruiting -
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Anaheim, California, United States Recruiting -
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Irvine, California, United States Recruiting -
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Long Beach, California, United States Recruiting -
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Los Angeles, California, United States Recruiting
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Coral Gables, Florida, United States Recruiting -
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Everett, Washington, United States Recruiting
Study contacts
- Study coordinator: Study Director
- Email: sol-adhd-304@axsome.com
- Phone: 212-332-5061
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Solriamfetol for children with ADHD: a 6-week comparison to placebo
This trial tests whether solriamfetol can help children aged 6 to under 12 with ADHD, compared to placebo, over six weeks.
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Impact of Sleep Timing and Duration on Teens with ADHD
This study tests how changing how long and when teens with ADHD sleep affects their attention and daily functioning.
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Health, Equity, and Resilience in Girls and Women with ADHD Across the Lifespan
This study tests health and well-being measures in girls and women with and without ADHD across Canada to see how ADHD relates to life phases and experiences.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.