A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD
Recruiting
Phase 3
Interventional Study
ADHD
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 11
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 468 (estimated)
- Sponsor
- Axsome Therapeutics, Inc. · Industry
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About This Trial
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 children aged 6 to \<12 years with ADHD.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or female, aged 6 to \<12 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.
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Contacts