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

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05113953
• Collaborator: (none)
• Enrollment: 147
• Locations: 25
• Arms: 3
• Anticipated Duration (Months): 8.6
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the efficacy of 2 doses of centanafadine sustained-release (SR) (200 mg and 400 mg total daily dose [TDD]) compared with placebo in adults with moderate to severe binge eating disorder (BED).

Condition or Disease	Intervention/Treatment	Phase
Binge-Eating Disorder	Drug: Centanafadine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 16, 2021
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Sep 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose: 200 mg Total Daily Dose (TDD) of Centanafadine 200 mg TTD of centanafadine will be administered as 1x 100 mg tablet and 1 placebo tablet twice daily (BID) 4-6 hours apart.	Drug: Centanafadine; Sustained-release oral tablets; Drug: Placebo; Oral tablets
Experimental: High Dose: 400 mg Total Daily Dose (TDD) of Centanafadine 400 mg TTD of centanafadine will be administered as 2x 100 mg tablets twice daily (BID) 4-6 hours apart.	Drug: Centanafadine; Sustained-release oral tablets
Placebo Comparator: Placebo Placebo will be administered as 2 placebo tablets twice daily (BID) 4-6 hours apart.	Drug: Placebo; Oral tablets

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Number of Binge Eating Days per Week [Baseline up to Week 8]

   Having a binge eating day is defined as a day with at least one binge eating episode.

Secondary Outcome Measures

1. Clinical Global Impression - Change (CGI-C) Score [Up to Week 8]

   CGI-C will be measured on a scale from 1-7 where a higher score indicates worse disease progression.

2. Change from Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score [Up to Week 8]

   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.

3. Number of Participants with Four-Week Cessation from Binging [Up to Week 8]

4. Change from Baseline in Number of Binge Episodes per Week [Up to Week 8]

5. Change from Baseline in Patient Global Impression - Severity (PGI-S) Score [Up to Week 8]

   PGI-S will be measured on a scale from 1-7 where a higher score indicates more severe symptoms.

6. Patient Global Impression - Change (PGI-C) Score [Up to Week 8]

   PGI-C will be measured on a scale from 1-7 where a higher score indicates a more severe disease progression.

7. Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score [Up to Week 8]

   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.

8. Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score [Up to Week 8]

   EDE-Q7 will be measured on a 7 item scale from 0-6 where a higher score indicates a more severe outcome.

9. Number of Participants with Adverse Events (AEs) [Day 1 up to 7 days after last dose of study treatment (up to approximately 9 weeks)]

10. Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score [Weeks 1, 2, 3, 4, 6, 8]

    CGI-S will be measured on a scale from 1-7 where a higher score indicates a more severe outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult participants 18 to 65 years of age (inclusive) at the time of informed consent.

• A primary diagnosis of binge eating disorder (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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT05113953
• Other Study ID Numbers: 405-201-00056
• First Posted: Nov 9, 2021
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: Centanafadine; Binge Eating Disorder
• Additional relevant MeSH terms: Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder

Study Results

No Results Posted as of Jul 28, 2022