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

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 Overview

• Status: Completed
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Centanafadine

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • NoesisPharma, LLC
  • California
    • Beverly Hills, California, United States, 90210
      • Southern California Research LLC
    • Encino, California, United States, 91316
      • Pharmacology Research Institute - San Fernando Valley
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Research, LLC
    • Upland, California, United States, 91786
      • Pacific Clinical Research Management Group LLC
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research, LLC
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions - Jacksonville
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Marietta, Georgia, United States, 30060
      • Psych Atlanta, PC
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
    • Prairie Village, Kansas, United States, 66208
      • Collective Medical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
  • Missouri
    • Weldon Spring, Missouri, United States, 63304
      • St. Charles Psychiatric Associates & Midwest Research Group
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices and Research - Portsmouth
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine
    • New York, New York, United States, 10128
      • Medical Research Network, LLC
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Craig and Frances Linder Center of Hope
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78737
      • Psychiatry + Psychotherapy Partners Austin
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 moderate severity.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Centanafadine 400 mg; Participants received centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks.	Drug: Centanafadine; Sustained-release oral tablets
Experimental: Centanafadine 200 mg; Participants received centanafadine 100 mg SR tablets, orally, BID at a TDD of 200 mg along with centanafadine matching placebo tablets, orally, BID for 8 weeks.	Drug: Placebo; Oral tablets; Drug: Centanafadine; Sustained-release oral tablets
Placebo Comparator: Placebo; Participants received centanafadine matching placebo tablets, orally, BID for 8 weeks.	Drug: Placebo; Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Number of Binge Eating Days per Week	Having a binge eating day is defined as a day with at least one binge eating episode.	Baseline up to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression - Change (CGI-C) Score	CGI-C will be measured on a scale from 1-7 where a higher score indicates worse disease progression.	Up to Week 8
Change from Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score	Y-BOCS-BE will be measured on a 10-item scale with each item rated from 0-4 where a higher score indicates more extreme symptoms.	Up to Week 8
Number of Participants with Four-Week Cessation from Binging		Up to Week 8
Change from Baseline in Number of Binge Episodes per Week		Up to Week 8
Change from Baseline in Patient Global Impression - Severity (PGI-S) Score	PGI-S will be measured on a scale from 1-7 where a higher score indicates more severe symptoms.	Up to Week 8
Patient Global Impression - Change (PGI-C) Score	PGI-C will be measured on a scale from 1-7 where a higher score indicates a more severe disease progression.	Up to Week 8
Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score	SF-36v2 will be measured on a scale from 1-100 where a lower total score (created by combining PCS and MCS scores) indicates a lower health-related quality of life.	Up to Week 8
Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score	EDE-Q7 will be measured on a 7 item scale from 0-6 where a higher score indicates a more severe outcome.	Up to Week 8
Number of Participants with Adverse Events (AEs)		Day 1 up to 7 days after last dose of study treatment (up to approximately 9 weeks)
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score	CGI-S will be measured on a scale from 1-7 where a higher score indicates a more severe outcome.	Weeks 1, 2, 3, 4, 6, 8

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Binge Eating Disorder; Centanafadine
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: 405-201-00056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No