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Norepinephrine-Dopamine Reuptake Inhibitor

Centanafadine 200 mg for Binge Eating Disorder

Phase 2
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 3, 4, 6, 8
Awards & highlights

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).

Eligible Conditions
  • Binge Eating Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 6, 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 6, 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Number of Binge Eating Days per Week
Secondary outcome measures
Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score
Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Centanafadine 400 mgExperimental Treatment1 Intervention
Participants received centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks.
Group II: Centanafadine 200 mgExperimental Treatment2 Interventions
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.
Group III: PlaceboPlacebo Group1 Intervention
Participants received centanafadine matching placebo tablets, orally, BID for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine
2019
Completed Phase 2
~300
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,902 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
2021. "A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113953.
~44 spots leftby Apr 2025
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