At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 374 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating Placebo and SPN-812 for Attention-Deficit/Hyperactivity Disorder (ADHD). Completed, enrolled 374 participants across 37 sites.
Detailed Summary
This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartNov 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedJul 11, 2019
Enrollment StartNov 20, 2019
Primary CompletionOct 10, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.0 years ago
Interventions
Placebodrug
Placebo will be administered once daily
SPN-812drug
SPN-812 will be administered once daily and compared to Placebo