NCT03107026

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of 2 doses of dasotraline (4 and 6 mg/day) versus placebo over a 12-week treatment period in adults with BED. This study is projected to randomize approximately 480 subjects to 3 treatment groups in a 1:1:1 ratio (4 mg/day dasotraline, 6 mg/day dasotraline, and placebo). Subjects randomized to placebo will receive placebo for the duration of the treatment period. Subjects randomized to 4 mg/day dasotraline will receive 4 mg/day for the duration of the treatment period. Subjects randomized to 6 mg/day dasotraline will be dosed with 4 mg/day dasotraline for the first 2 weeks of the treatment period and will be increased to 6 mg/day at Week 2. If, in the judgment of the Investigator, the subject does not tolerate the assigned dose, he or she will be discontinued from the study. The study will consist of 3 periods: Screening (up to 3 weeks), 12-weeks of treatment, and a 3-week study drug withdrawal period. Subjects who complete the 12-week double-blind treatment period in this study may be eligible to enroll and continue treatment for an additional 12 months in an open-label extension study (Study SEP360-322). Subjects who do not enter the extension study will complete the study drug withdrawal period in this study.

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	dasotraline 4mg	dasotraline 4mg tablet once daily
DRUG	dasotraline 6mg	dasotraline 6mg tablet once daily
DRUG	Placebo	Placebo tablet once daily

Timeline

• Start date: 2017-03-31
• Primary completion: 2018-05-16
• Completion: 2018-05-16
• First posted: 2017-04-11
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study