A Phase 3 interventional study of Solriamfetol in ADHD, sponsored by Axsome Therapeutics, Inc.. Enrolling by invitation at 10 sites in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
Eligible subjects are children and adolescents with ADHD who have completed either Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). Subjects will be assigned to age-based cohorts and will receive solriamfetol once daily for up to 52 weeks.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 300 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to 52 weeks
Drug: Solriamfetol
Solriamfetol capsules, taken once daily
Treatment-Emergent Adverse Events (TEAEs)
An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.
Time frame: Up to 52 weeks
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Solriamfetol
Attention Deficit Disorder with Hyperactivity →