Clinical Trial

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

Recruiting Phase 4
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Record status
This record was last updated February 18, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2021-03-01; most recent amendment 2026-02-16.
Status change: Not Yet Recruiting → Recruiting 2024-03-22
Trial Details
NCT Number NCT04781140
Lead Sponsor Supernus Pharmaceuticals, Inc.
Conditions Attention-Deficit/Hyperactivity Disorder
Enrollment 286 participants
Start Date 2024-03-19
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-18