At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 310 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
200mg 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) 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
In Brief
A Phase 3 clinical trial evaluating Placebo, 200mg SPN-812, and 1 other intervention for ADHD. Completed, enrolled 310 participants across 12 sites.
Detailed Summary
This study will evaluate the efficacy and safety of low doses of SPN-812 in adolescents 12-17 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartNov 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedAug 11, 2017
Enrollment StartNov 2, 2017
Primary CompletionOct 17, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.9 years ago
Interventions
Placebodrug
Placebo was administered once daily
200mg SPN-812drug
200mg SPN-812 was administered once daily and compared to placebo
400mg SPN-812drug
400mg SPN-812 was administered once daily and compared to placebo