Phase 2
N=147
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
Binge-Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05113953 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Number of Binge Eating Days Per Week — -3.44; -3.07; -3.01 binge eating days per week — p=0.1893
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Centanafadine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Binge Eating Days Per Week |
-3.44; -3.07; -3.01 | 0.1893 |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score |
— | — |
| SECONDARY 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) |
34; 28; 24; 5; 3; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities |
1; 0; 0; 0; 1; 3 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Abnormalities |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Study Medication Withdrawal Questionnaire (SMWQ) Total Mean Score |
5.56; 7.72; 6.40 | — |
| SECONDARY Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score |
-1.23; 0.55; -1.20 | — |
| SECONDARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-0.20; 0.00; -1.20 | — |
| SECONDARY Number of Participants With Suicidality as Measured by Columbia Suicide Severity Rating Scale (C-SSRS) Score |
0; 1; 0 | — |
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).
Eligibility Criteria
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 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.
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.
Data sourced from ClinicalTrials.gov (NCT05113953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.