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

Sponsor ID
405-201-00056
Clinicaltrials.gov ID
NCT05113953
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00056
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Eating Disorder
    • Sex
    Female & Male
    Trial Dates
    Dec 2021 - Aug 2022
    Healthy Volunteers
    No
    • 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.
    • 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.

    Study 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).

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Centanafadine
    Type
    Interventional
    Masking
    Double
    Estimated Enrollment
    147
    Additional Study Details

    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).

    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.
    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.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    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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