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

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Centanafadine
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Centanafadine, Binge Eating Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NoesisPharma, LLC
  • Southern California Research LLC
  • Pharmacology Research Institute - San Fernando Valley
  • Collaborative Neuroscience Research, LLC
  • Pacific Clinical Research Management Group LLC
  • Mountain View Clinical Research, LLC
  • Clinical Neuroscience Solutions - Jacksonville
  • Miami Dade Medical Research Institute
  • iResearch Atlanta
  • Psych Atlanta, PC
  • Psychiatric Associates
  • Collective Medical Research
  • Boston Clinical Trials
  • St. Charles Psychiatric Associates & Midwest Research Group
  • ActivMed Practices and Research - Portsmouth
  • Center for Emotional Fitness
  • Princeton Medical Institute
  • Manhattan Behavioral Medicine
  • Medical Research Network, LLC
  • Richmond Behavioral Associates
  • Midwest Clinical Research Center
  • Craig and Frances Linder Center of Hope
  • Clinical Neuroscience Solutions, Inc.
  • Psychiatry + Psychotherapy Partners Austin
  • FutureSearch Trials - Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Centanafadine 400 mg

Centanafadine 200 mg

Placebo

Arm Description

Participants received centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks.

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.

Participants received centanafadine matching placebo tablets, orally, BID for 8 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline in Number of Binge Eating Days per Week
Having a binge eating day is defined as a day with at least one binge eating episode.

Secondary Outcome Measures

Clinical Global Impression - Change (CGI-C) Score
CGI-C will be measured on a scale from 1-7 where a higher score indicates worse disease progression.
Change from Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score
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.
Number of Participants with Four-Week Cessation from Binging
Change from Baseline in Number of Binge Episodes per Week
Change from Baseline in Patient Global Impression - Severity (PGI-S) Score
PGI-S will be measured on a scale from 1-7 where a higher score indicates more severe symptoms.
Patient Global Impression - Change (PGI-C) Score
PGI-C will be measured on a scale from 1-7 where a higher score indicates a more severe disease progression.
Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score
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.
Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score
EDE-Q7 will be measured on a 7 item scale from 0-6 where a higher score indicates a more severe outcome.
Number of Participants with Adverse Events (AEs)
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score
CGI-S will be measured on a scale from 1-7 where a higher score indicates a more severe outcome.

Full Information

First Posted
October 7, 2021
Last Updated
August 25, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05113953
Brief Title
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder
Keywords
Centanafadine, Binge Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Centanafadine 400 mg
Arm Type
Experimental
Arm Description
Participants received centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks.
Arm Title
Centanafadine 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received centanafadine matching placebo tablets, orally, BID for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Centanafadine
Intervention Description
Sustained-release oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Change from Baseline in Number of Binge Eating Days per Week
Description
Having a binge eating day is defined as a day with at least one binge eating episode.
Time Frame
Baseline up to Week 8
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Change (CGI-C) Score
Description
CGI-C will be measured on a scale from 1-7 where a higher score indicates worse disease progression.
Time Frame
Up to Week 8
Title
Change from Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score
Description
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.
Time Frame
Up to Week 8
Title
Number of Participants with Four-Week Cessation from Binging
Time Frame
Up to Week 8
Title
Change from Baseline in Number of Binge Episodes per Week
Time Frame
Up to Week 8
Title
Change from Baseline in Patient Global Impression - Severity (PGI-S) Score
Description
PGI-S will be measured on a scale from 1-7 where a higher score indicates more severe symptoms.
Time Frame
Up to Week 8
Title
Patient Global Impression - Change (PGI-C) Score
Description
PGI-C will be measured on a scale from 1-7 where a higher score indicates a more severe disease progression.
Time Frame
Up to Week 8
Title
Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score
Description
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.
Time Frame
Up to Week 8
Title
Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score
Description
EDE-Q7 will be measured on a 7 item scale from 0-6 where a higher score indicates a more severe outcome.
Time Frame
Up to Week 8
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Day 1 up to 7 days after last dose of study treatment (up to approximately 9 weeks)
Title
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score
Description
CGI-S will be measured on a scale from 1-7 where a higher score indicates a more severe outcome.
Time Frame
Weeks 1, 2, 3, 4, 6, 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
NoesisPharma, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Southern California Research LLC
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Pharmacology Research Institute - San Fernando Valley
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pacific Clinical Research Management Group LLC
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Mountain View Clinical Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Clinical Neuroscience Solutions - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Psych Atlanta, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Collective Medical Research
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
St. Charles Psychiatric Associates & Midwest Research Group
City
Weldon Spring
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
ActivMed Practices and Research - Portsmouth
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Craig and Frances Linder Center of Hope
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Psychiatry + Psychotherapy Partners Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
FutureSearch Trials - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing URL
https://clinical-trials.otsuka.com

Learn more about this trial

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

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