CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 132 enrolled
Drug / intervention
dasotraline 4mg +1 moredrug
Likely dose
dasotraline 4mgfrom 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.

Search/NCT02734693
NCT02734693Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of Dasotraline in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Sumitomo Pharma America, Inc.·interventional·Posted Apr 12, 2016·Updated Mar 27, 2020

In Brief

A Phase 3 clinical trial evaluating dasotraline 4mg and Placebo for Attention-Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 132 participants across 5 sites.

Detailed Summary

A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit Hyperactivity Disorder (ADHD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 12, 2016
Enrollment StartApr 30, 2016
Primary CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.2 years ago

Interventions

dasotraline 4mgdrug

dasotraline 4mg/day

Placeboother

placebo/day