At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 297 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
400mg SPN-812from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
In Brief
A Phase 3 clinical trial evaluating Placebo, 400mg SPN-812, and 1 other intervention for ADHD. Completed, enrolled 297 participants across 14 sites.
Detailed Summary
This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartNov 2017
Primary CompletionFeb 2019
TodayJul 2026
First PostedAug 11, 2017
Enrollment StartNov 20, 2017
Primary CompletionFeb 14, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.9 years ago
Interventions
Placebodrug
Placebo was administered once daily
400mg SPN-812drug
400mg SPN-812 was administered once daily and compared to Placebo
600mg SPN-812drug
600mg SPN-812 was administered once daily and compared to Placebo