An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
Part of paid clinical trials in Dothan, Alabama.
- Sponsor
- Axsome Therapeutics, Inc.
- Study ID
- NCT07773883
- Phase
- PHASE3
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Solriamfetol — DRUGSolriamfetol capsules, taken once daily
Study Details
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.
Key Dates
- First listed
- Aug 19, 2026
- Start date
- Aug 6, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SolriamfetolUp to 52 weeks
Primary Outcome Measure
Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 52 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Research Site | Dothan | Alabama | 36303 | - |
| Clinical Research Site | Maitland | Florida | 32751 | - |
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