At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 96 enrolled
Drug / intervention
SPN-812drug
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 IV, Open-Label, Flexible-Dose Safety Trial Evaluating SPN-812 Administered With Psychostimulants in Children and Adolescents (6 to 17 Years of Age) With Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 4 clinical trial evaluating SPN-812 for Attention-Deficit/Hyperactivity Disorder (ADHD). Completed, enrolled 96 participants across 17 sites in 2 countries.
Detailed Summary
This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartJul 2021
Primary CompletionMay 2023
Study CompletionJul 2023
TodayJul 2026
First PostedMar 8, 2021
Enrollment StartJul 27, 2021
Primary CompletionMay 23, 2023
Study CompletionJul 26, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.3 years ago
Interventions
SPN-812drug
Viloxazine extended-release capsule