Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Solriamfetol Dose A for ADHD

This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in children aged 6 to \<12 years with ADHD.

Official registry: https://clinicaltrials.gov/study/NCT07717879 · Axsome Therapeutics, Inc. · enrollment listed as 468

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Solriamfetol Dose A, Solriamfetol Dose B, or Placebo. The registry lists allocation as randomized. This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in children aged 6 to \<12 years with ADHD.

They plan to enroll about 468 people at 31 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Solriamfetol Dose A, Solriamfetol Dose B, Placebo

Primary outcome (registry wording): ADHD-RS-5 Total Score, Change from Baseline to Week 6

Who it is for (from inclusion criteria)

  • Ages 6 Years to 11 Years
  • Male or female, aged 6 to \<12 years
  • Primary diagnosis of ADHD according to DSM-5 criteria

Public study contact (from the registry)

Study Director

212-332-5061

sol-adhd-302@axsome.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

31 listed

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FAQ about this NCT record

Is NCT07717879 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07717879?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07717879?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary