A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess the efficacy of 2 doses of centanafadine sustained-release (SR) (200 mg and 400 mg total daily dose [TDD]) compared with placebo in adults with moderate to severe binge eating disorder (BED).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

• Adult participants 18 to 65 years of age (inclusive) at the time of informed consent.

• A primary diagnosis of binge eating disorder (BED), or is diagnosed at screening, according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Structured Clinical Interview for DSM-5 (SCID).

• BED with a history of at least moderate severity.

• A rating of 4 or higher on the Clinical Global Impression - Severity (CGI-S) at screening and baseline.

• Body mass index (BMI) of 18 to 45 kg/m^2, inclusive.

Exclusion Criteria:

• Lifetime history of bulimia nervosa or anorexia nervosa.

• Participation in a formal weight loss program within 3 months of screening or planning to start a weight loss program during the trial.

• History of bariatric surgery.

• Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 18.