NCT07717892 Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
| NCT ID | NCT07717892 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 468 participants |
| Start Date | 2026-06-25 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 468 participants in total. It began in 2026-06-25 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 adolescents aged 12 to \<18 years with ADHD.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07717892 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07717892 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 468 participants.
Is NCT07717892 currently recruiting?
Yes, NCT07717892 is actively recruiting participants. Contact the research team at sol-adhd-304@axsome.com for enrollment information.
Where is the NCT07717892 trial being conducted?
This trial is being conducted at Dothan, United States, Little Rock, United States, Irvine, United States, Long Beach, United States and 11 additional locations.
Who is sponsoring the NCT07717892 clinical trial?
NCT07717892 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 468 participants.