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A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05113953•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult participants 18 to 65 years of age (inclusive) at the time of informed consent.
•A primary diagnosis of 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 2 binge eating days per week for 6 months prior to screening.
•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.

Locations (25)

NoesisPharma, LLC

Phoenix, Arizona, United States

Southern California Research LLC

Beverly Hills, California, United States

Pharmacology Research Institute - San Fernando Valley

Encino, California, United States

Collaborative Neuroscience Research, LLC

Garden Grove, California, United States

Pacific Clinical Research Management Group LLC

Upland, California, United States

Mountain View Clinical Research, LLC

Denver, Colorado, United States

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

iResearch Atlanta

Decatur, Georgia, United States

Psych Atlanta, PC

Marietta, Georgia, United States

Key Dates

Start Date

December 22, 2021

Primary Completion Date

August 19, 2022

Completion Date

August 19, 2022

Last Updated

September 9, 2025

Enrollment

147

ACTUAL participants

Conditions

Binge-Eating Disorder

Interventions

Centanafadine

DRUG

Placebo

DRUG

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Binge-Eating DisorderBulimia Nervosa+2 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans

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