Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Dasotraline Long-term Safety in Binge Eating Disorder
NCT02684279Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2016
- Primary completion
- Jun 2019
- Countries
- 1
- Sponsor
- Sumitomo Pharma America
- Modality
- Small Molecules
- Drugs
- dasotraline
- Conditions
- binge eating disorder (BED)
01
Overview
Phase 3, open-label, single-arm trial of dasotraline in binge eating disorder (BED), sponsored by Sumitomo Pharma America. Primary endpoints: Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale and Frequency and Severity of Suicidal Behavior Using the C-SSRS. Started Feb 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Dasotraline
Dasotraline 4, 6, 8 mg flexibly dosed
03
Who it enrols
Adults with Binge Eating Disorder who completed the treatment period of a dasotraline core study (SEP360-221 or SEP360-321).
04
Endpoints
Primary
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Secondary
Change in Body Weight
Percent Change in Body Weight
Change in Body Mass Index
Change in Fasting Lipid Panel, Triglycerides
Change in Fasting Lipid Panel, Total Cholesterol
Change in Fasting Lipid Panel, High-density Lipoprotein Cholesterol
Change in Fasting Lipid Panel, Low-density Lipoprotein Cholesterol
Change in Hemoglobin A1c Levels
Beyond the preview
Go deeper on NCT02684279.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02684279.