NCT02564588

Dasotraline Binge Eating Disorder Study

A 12-week, Randomized, Double-blind, Parallel-group, Placebo Controlled, Flexibly Dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with moderate to severe Binge Eating Disorder (BED)

Detailed description

This is a randomized, double blind, parallel group, multicenter, outpatient study evaluating the efficacy and safety of flexibly-dosed dasotraline in adults with BED using dasotraline (4, 6, and 8 mg/day) versus placebo over a 12 week treatment period.

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	Dasotraline	Dasotraline 4, 6, 8mg flexibly dosed once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-09-30
• Last updated: 2017-09-28

Locations

43 sites across 1 country: United States