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Enrolling By Invitation
NCT07773883
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
Conditions: ADHD
Sex: All
Ages: 6 Years – 18 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Axsome Therapeutics, Inc.
Location: Clinical Research Site Dothan Alabama
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3).
* Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study.
Exclusion Criteria:
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
Source: ClinicalTrials.gov (NCT07773883). StuddyBuddy aggregates publicly available trial information.