At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
dasotraline +1 moredrug
Likely dose
dasotraline 2mgfrom 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.
Dasotraline (2mg) in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety in a Laboratory Classroom Setting
In Brief
A Phase 3 clinical trial evaluating dasotraline and Placebo for Attention-Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 95 participants across 8 sites.
Detailed Summary
A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartJul 2017
Primary CompletionMar 2019
TodayJul 2026
First PostedJul 27, 2017
Enrollment StartJul 31, 2017
Primary CompletionMar 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.9 years ago
Interventions
dasotralinedrug
dasotraline 2mg capsule once daily
Placebodrug
Placebo capsule once daily