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

Study Identifier:
405-201-00056
ClinicalTrials.gov Identifier:
NCT05113953
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Available

Study Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Study Details

Medical Condition
  • Eating Disorder
Study Drug
  • Drug: Centanafadine
  • Drug: Placebo
Date
Dec 2021 - Aug 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
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.

Protocol 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).

Study Locations

Location
Status
Location
NoesisPharma, LLC
Phoenix, Arizona, United States, 85016
Status
N/A
Location
Southern California Research LLC
Beverly Hills, California, United States, 90210
Status
N/A
Location
Pharmacology Research Institute - San Fernando Valley
Encino, California, United States, 91316
Status
N/A
Location
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States, 92845
Status
N/A
Location
Pacific Clinical Research Management Group LLC
Upland, California, United States, 91786
Status
N/A
Location
Mountain View Clinical Research, LLC
Denver, Colorado, United States, 80209
Status
N/A
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
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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