At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 477 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
100mg 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) 100 and 200 mg Efficacy and Safety in Children With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
In Brief
A Phase 3 clinical trial evaluating Placebo, 100mg SPN-812, and 1 other intervention for ADHD. Completed, enrolled 477 participants across 7 sites.
Detailed Summary
This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11 years of age diagnosed with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartOct 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedAug 11, 2017
Enrollment StartOct 20, 2017
Primary CompletionSep 12, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.9 years ago
Interventions
Placebodrug
Placebo was administered once daily
100mg SPN-812drug
100mg SPN-812 was administered once daily and compared to placebo
200mg SPN-812drug
200mg SPN-812 was administered once daily and compared to placebo