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

Binge-Eating Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113953
• Other study ID #: 405-201-00056
• Status: Completed
• Phase: Phase 2
• Start date: December 16, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2023
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• Centanafadine
Sustained-release oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
United States	Psychiatry + Psychotherapy Partners Austin	Austin	Texas
United States	Southern California Research LLC	Beverly Hills	California
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	FutureSearch Trials - Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Mountain View Clinical Research, LLC	Denver	Colorado
United States	Pharmacology Research Institute - San Fernando Valley	Encino	California
United States	Collaborative Neuroscience Research, LLC	Garden Grove	California
United States	Clinical Neuroscience Solutions - Jacksonville	Jacksonville	Florida
United States	Psych Atlanta, PC	Marietta	Georgia
United States	Craig and Frances Linder Center of Hope	Mason	Ohio
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	Manhattan Behavioral Medicine	New York	New York
United States	Medical Research Network, LLC	New York	New York
United States	Psychiatric Associates	Overland Park	Kansas
United States	NoesisPharma, LLC	Phoenix	Arizona
United States	ActivMed Practices and Research - Portsmouth	Portsmouth	New Hampshire
United States	Collective Medical Research	Prairie Village	Kansas
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Pacific Clinical Research Management Group LLC	Upland	California
United States	St. Charles Psychiatric Associates & Midwest Research Group	Weldon Spring	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants with Four-Week Cessation from Binging		Up to Week 8
Secondary	Change from Baseline in Number of Binge Episodes per Week		Up to Week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants with Adverse Events (AEs)		Day 1 up to 7 days after last dose of study treatment (up to approximately 9 weeks)
Secondary	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