Clinical trial NCT05113953: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Binge-Eating Disorder
Keywords: Centanafadine
Binge Eating Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change from Baseline in Number of Binge Eating Days per Week
timeFrame: Baseline up to Week 8
Secondary outcomes:
measure: Clinical Global Impression - Change (CGI-C) Score
timeFrame: Up to Week 8
measure: Change from Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score
timeFrame: Up to Week 8
measure: Number of Participants with Four-Week Cessation from Binging
timeFrame: Up to Week 8
measure: Change from Baseline in Number of Binge Episodes per Week
timeFrame: Up to Week 8
measure: Change from Baseline in Patient Global Impression - Severity (PGI-S) Score
timeFrame: Up to Week 8
measure: Patient Global Impression - Change (PGI-C) Score
timeFrame: Up to Week 8
measure: Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score
timeFrame: Up to Week 8
measure: Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score
timeFrame: Up to Week 8
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Day 1 up to 7 days after last dose of study treatment (up to approximately 9 weeks)
measure: Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Weeks 1, 2, 3, 4, 6, 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NoesisPharma, LLC
state: Arizona
city: Beverly Hills
country: United States
facility: Southern California Research LLC
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute - San Fernando Valley
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research, LLC
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions - Jacksonville
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta, PC
state: Georgia
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Prairie Village
country: United States
facility: Collective Medical Research
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Weldon Spring
country: United States
facility: St. Charles Psychiatric Associates & Midwest Research Group
state: Missouri
city: Portsmouth
country: United States
facility: ActivMed Practices and Research - Portsmouth
state: New Hampshire
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: New York
country: United States
facility: Medical Research Network, LLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Craig and Frances Linder Center of Hope
state: Ohio
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Psychiatry + Psychotherapy Partners Austin
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials - Dallas
state: Texas
Study officials:
References: