NCT05118906已完成2 期
A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Binge Eating episodes per week
研究概览
简要总结
This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.
详细描述
First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures.
- •Female aged between 18 and 65 years, inclusive.
- •Diagnosis of BED according to DSM-5 criteria
- •BMI < 50 kg/m2.
排除标准
- •Current diagnosis of bulimia nervosa or anorexia nervosa.
- •History of bariatric surgery.
- •Patient who is pregnant, lactating, or of childbearing potential who is not using adequate contraceptive measures. The following are considered adequate methods of birth control:
- •intrauterine device (IUD);
- •barrier protection;
- •contraceptive implantation system;
- •oral contraceptive pills;
- •surgically sterile patient; and
- •abstinence. All participants should have a negative pregnancy test prior to randomization
- •Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).
研究组 & 干预措施
BP1.4979
Experimental
15 mg BID active treatment
干预措施: BP1.4979 active drug (Drug)
Placebo
Placebo Comparator
matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Binge Eating episodes per week
时间窗: 8 weeks
Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period
次要结局
- Binge Eating days per week(8 weeks)
- Quality of Life improvement (CGI-I)(8 weeks)
研究者
研究点 (1)
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