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NCT05113953 · ClinicalTrials.gov registry record · Phase 2
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT05113953: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT05113953 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05113953, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Centanafadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2021-12-22 |
| Est. Completion | 2022-08-19 |
| Phase | Phase 2 |
What the finished NCT05113953 record still lists
NCT05113953 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05113953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05113953 about?
NCT05113953 is a clinical study titled "A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder". 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).
What is the current status of trial NCT05113953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2021-12-22. Estimated completion is 2022-08-19.
What interventions are being tested in trial NCT05113953?
The interventions under investigation include: Placebo (DRUG), Centanafadine (DRUG).
Who is sponsoring clinical trial NCT05113953?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05113953's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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