At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 491 enrolled
Drug / intervention
dasotraline 4mg +2 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.
A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder
In Brief
A Phase 3 clinical trial evaluating dasotraline 4mg, dasotraline 6mg, and 1 other intervention for Binge Eating Disorder. Completed, enrolled 491 participants across 50 sites.
Detailed Summary
A study to evaluate a drug (dasotraline) on the safety, effectiveness and how well the body tolerates it, in adults with moderate to severe binge eating disorder
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge Eating Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedApr 2017
Primary CompletionMay 2018
TodayJul 2026
First PostedApr 11, 2017
Enrollment StartMar 31, 2017
Primary CompletionMay 16, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.2 years ago
Interventions
dasotraline 4mgdrug
dasotraline 4mg tablet once daily
dasotraline 6mgdrug
dasotraline 6mg tablet once daily
Placebodrug
Placebo tablet once daily