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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Binge-Eating Disorder

Treatments: Drug: Centanafadine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05113953

405-201-00056

Details and patient eligibility

About

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).

Enrollment: 147 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 3 patient groups, including a placebo group

Centanafadine 400 mg

Experimental group

Description:

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

Treatment:

Drug: Centanafadine

Centanafadine 200 mg

Experimental group

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.

Treatment:

Drug: Centanafadine

Drug: Placebo

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo