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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Binge-Eating Disorder

Intervention / Treatment
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* Drug: Centanafadine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Centanafadine, Binge Eating Disorder