At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 237 enrolled
Drug / intervention
Dasotralinedrug
Likely dose
Dasotraline 2 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, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating Dasotraline for Attention Deficit Hyperactivity Disorder. Completed, enrolled 237 participants across 36 sites.
Detailed Summary
This is an open label 26 week extension study for subjects who completed SEP360-202.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionFeb 2017
TodayJul 2026
First PostedMay 29, 2015
Enrollment StartJun 30, 2015
Primary CompletionFeb 2, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.1 years ago
Interventions
Dasotralinedrug
Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed