NCT05113953

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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets After Oral Administration in Adult Subjects With Binge Eating Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	Centanafadine	Sustained-release oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2021-12-22
• Primary completion: 2022-08-19
• Completion: 2022-08-19
• First posted: 2021-11-09
• Last updated: 2025-09-09
• Results posted: 2025-09-09

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study