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RecruitingPhase 3

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)

Axsome Therapeutics, Inc. · NCT07717892

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
468
US sites recruiting
28
Study start
June 25, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Solriamfetol Dose A; Solriamfetol Dose B; Placebo

Conditions: ADHD

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Study Director · 212-332-5061 · sol-adhd-304@axsome.com
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Forward Treatment of Attention Deficit and Hyperactivity Using… (NCT07717892) | Bored Studies