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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 25
- 主要终点
- Change From Baseline in Number of Binge Eating Days Per Week
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 2 binge eating days per week for 6 months prior to screening.
- •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.
排除标准
- •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.
研究组 & 干预措施
Centanafadine 400 mg
Participants will receive centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks.
干预措施: Centanafadine (Drug)
Centanafadine 200 mg
Participants will receive centanafadine 100 mg SR tablets, orally, BID at a TDD of 200 mg along with centanafadine matching placebo tablets, orally, BID for 8 weeks.
干预措施: Centanafadine (Drug)
Centanafadine 200 mg
Participants will receive centanafadine 100 mg SR tablets, orally, BID at a TDD of 200 mg along with centanafadine matching placebo tablets, orally, BID for 8 weeks.
干预措施: Placebo (Drug)
Placebo
Participants will receive centanafadine matching placebo tablets, orally, BID for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Number of Binge Eating Days Per Week
时间窗: Baseline, Weeks 7 to 8
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.
次要结局
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline, Week 8)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score(Baseline, Week 8)
- Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Abnormalities(From first dose of study drug up to 1 week post last dose (Up to 9 weeks))
- Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs)(From first dose of study drug up to 1 week post last dose (Up to 9 weeks))
- Study Medication Withdrawal Questionnaire (SMWQ) Total Mean Score(Week 8)
- Number of Participants With Suicidality as Measured by Columbia Suicide Severity Rating Scale (C-SSRS) Score(Week 8)
- Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities(From first dose of study drug up to 1 week post last dose (Up to 9 weeks))
- Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities(From first dose of study drug up to 1 week post last dose (Up to 9 weeks))
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline, Week 8)