A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge-eating disorder (BED). An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder.
详细描述
Following screening, eligible subjects will be randomized in a 1:1 ratio to RDC-0313 (ALKS 33) or matching placebo. Once-daily at-home dosing will begin at randomization and will continue for 6 weeks. There will be 8 study visits over a 12-week study period. On an ongoing basis, subjects will complete a take-home binge diary designed to record the number of binge-eating episodes (binge episodes) and binge-eating days (binge days, days during which at least 1 binge occurred), as well as snacks and meals consumed daily over each 7-day period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED)
- •Display greater than or equal to 3 binge eating days per week
- •Body mass index (BMI) greater than or equal to 30 kg/m2
- •Age of 18 years or older
- •Women of childbearing potential must agree to use an approved method of birth control for the duration of the study
排除标准
- •Concurrent symptoms of bulimia nervosa or anorexia nervosa
- •Suicidal ideation
- •DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
- •Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
- •Women who are pregnant or breastfeeding
- •Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening
- •Clinically unstable medical disease
- •History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- •History of seizures, including clinically significant febrile seizures in childhood
- •Current or anticipated need for prescribed opioid medication during the study period
- •Use of any psychotropic medications (other than hypnotics)
- •Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
研究组 & 干预措施
RDC-0313 (ALKS 33)
2-capsules taken orally
干预措施: RDC-0313 (ALKS 33) (Drug)
Placebo
2-capsules taken orally
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
时间窗: 6 Weeks
A TEAE is any adverse event (AE), regardless of causality, that either: begins after a participant's first dose of study drug, up to and including the final follow-up visit; or started before a participant's first dose of study drug but worsens in severity after the first dose of study drug, up to and including the final follow-up visit.
次要结局
未报告次要终点