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COMPLETEDPhase 2NCT05113953

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

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 ad...

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.•25 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 9, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment147

Start dateDec 2021

Last updatedSep 9, 2025

Condition

Binge-Eating Disorder

Locations shown

NoesisPharma, LLC

Phoenix, Arizona

Southern California Research LLC

Beverly Hills, California

Pharmacology Research Institute - San Fernando Valley

Encino, California

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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: May 10, 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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