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

Phase 3 Completed 491 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2017-03-31
Primary completion: 2018-05-16
Completion: 2018-05-16

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Dasotraline 6mg; p = 0.0045; Mean Difference (Final Values) -0.55 (95% CI -0.93 to -0.17) NCT03107026 ↗

Publications

Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasotraline	Small molecule	4 mg	—
Subject	Dasotraline	Small molecule	6 mg	—