Binge eating disorder
Conditions
Brief summary
The primary efficacy endpoint will be the change in the total number of binge-eating (BE) episodes per week based on the self-reported BE diaries, from the 2-week baseline (Day-14 to Day 0) compared to the last 2 weeks at the end of treatment period (Day 43 to Day 56).
Detailed description
Continuous Glucose Monitoring System (CGMS): to assess the number of dietary intakes (glycemic excursions) between meals identified as BE episodes by the Investigator., Change of the Yale Food Addiction Scale (YFAS) from baseline to Week 8., Change of the Clinical Global Impression (CGI) scale: CGI-Severity (CGI-S) and CGI-Improvement (CGI-I) from baseline to Week 8., Change in the number of BE days per week from baseline to Week 7 and Week 8.
Interventions
Sponsors
Bioprojet Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the change in the total number of binge-eating (BE) episodes per week based on the self-reported BE diaries, from the 2-week baseline (Day-14 to Day 0) compared to the last 2 weeks at the end of treatment period (Day 43 to Day 56). | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous Glucose Monitoring System (CGMS): to assess the number of dietary intakes (glycemic excursions) between meals identified as BE episodes by the Investigator., Change of the Yale Food Addiction Scale (YFAS) from baseline to Week 8., Change of the Clinical Global Impression (CGI) scale: CGI-Severity (CGI-S) and CGI-Improvement (CGI-I) from baseline to Week 8., Change in the number of BE days per week from baseline to Week 7 and Week 8. | — |
Countries
France, Spain
Outcome results
None listed