At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 159 enrolled
Drug / intervention
SPN-812drug
Likely dose
SPN-812 600 mgfrom 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.
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating SPN-812 for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 159 participants across 38 sites.
Detailed Summary
Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 in adult ADHD patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartJan 2020
Primary CompletionJul 2022
Study CompletionDec 2022
TodayJul 2026
First PostedOct 29, 2019
Enrollment StartJan 23, 2020
Primary CompletionJul 26, 2022
Study CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.7 years ago
Interventions
SPN-812drug
SPN-812 200 to 600 mg/day