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
1 other identifier
interventional
147
1 country
25
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedStudy Start
First participant enrolled
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2022
CompletedResults Posted
Study results publicly available
September 9, 2025
CompletedSeptember 9, 2025
August 1, 2025
8 months
October 7, 2021
August 19, 2025
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Number of Binge Eating Days Per Week
Binge eating day was defined as a day with at least one binge eating episode. Least squares (LS) mean was determined by Mixed-effect Model Repeated Measures (MMRM) method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, and an interaction term of treatment by visit week.
Baseline, Weeks 7 to 8
Secondary Outcomes (9)
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score
Baseline, Week 8
Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs)
From first dose of study drug up to 1 week post last dose (Up to 9 weeks)
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities
From first dose of study drug up to 1 week post last dose (Up to 9 weeks)
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities
From first dose of study drug up to 1 week post last dose (Up to 9 weeks)
Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Abnormalities
From first dose of study drug up to 1 week post last dose (Up to 9 weeks)
- +4 more secondary outcomes
Other Outcomes (9)
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score
Baseline, Weeks 1, 2, 3, 4, and 6
Mean Clinical Global Impression - Change (CGI-C) Score
Week 8
Change From Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score
Baseline, Week 8
- +6 more other outcomes
Study Arms (3)
Centanafadine 400 mg
EXPERIMENTALParticipants will receive centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks.
Centanafadine 200 mg
EXPERIMENTALParticipants will receive centanafadine 100 mg SR tablets, orally, BID at a TDD of 200 mg along with centanafadine matching placebo tablets, orally, BID for 8 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive centanafadine matching placebo tablets, orally, BID for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
NoesisPharma, LLC
Phoenix, Arizona, 85016, United States
Southern California Research LLC
Beverly Hills, California, 90210, United States
Pharmacology Research Institute - San Fernando Valley
Encino, California, 91316, United States
Collaborative Neuroscience Research, LLC
Garden Grove, California, 92845, United States
Pacific Clinical Research Management Group LLC
Upland, California, 91786, United States
Mountain View Clinical Research, LLC
Denver, Colorado, 80209, United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256, United States
Miami Dade Medical Research Institute
Miami, Florida, 33176, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Psych Atlanta, PC
Marietta, Georgia, 30060, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Collective Medical Research
Prairie Village, Kansas, 66208, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
St. Charles Psychiatric Associates & Midwest Research Group
Weldon Spring, Missouri, 63304, United States
ActivMed Practices and Research - Portsmouth
Portsmouth, New Hampshire, 03801, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
Medical Research Network, LLC
New York, New York, 10128, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Craig and Frances Linder Center of Hope
Mason, Ohio, 45040, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Psychiatry + Psychotherapy Partners Austin
Austin, Texas, 78737, United States
FutureSearch Trials - Dallas
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2021
First Posted
November 9, 2021
Study Start
December 22, 2021
Primary Completion
August 19, 2022
Study Completion
August 19, 2022
Last Updated
September 9, 2025
Results First Posted
September 9, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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.