NCT01291173已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With 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
- Shire
- 入组人数
- 271
- 试验地点
- 29
- 主要终点
- Change From Baseline in Log Transformed Binge Days Per Week at Week 11
研究概览
简要总结
To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SPD489 30 mg
Experimental
干预措施: lisdexamfetamine dimesylate (SPD489) (Drug)
SPD489 50 mg
Experimental
干预措施: lisdexamfetamine dimesylate (SPD489) (Drug)
SPD489 70 mg
Experimental
干预措施: lisdexamfetamine dimesylate (SPD489) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Log Transformed Binge Days Per Week at Week 11
时间窗: Baseline and week 11
Binge day is defined as a day during which at least 1 binge episode occurs.
次要结局
- Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11(Baseline and week 11)
- Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks(Baseline and up to 11 weeks)
- Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11(Baseline and week 11)
- Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11(Baseline and week 11)
- 1-Week Binge Response, Last Observation Carried Forward (LOCF)(Last 7 days on study)
- 4-Week Binge Response(Last 28 days on study)
- Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline(Baseline)
- Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks(up to 11 weeks)
- Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks(Up to 11 weeks)
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11(Baseline and week 11)
- Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11(Baseline and week 11)
- Change From Baseline in Eating Inventory Score at Week 11(Baseline and week 11)
- Change From Baseline in Binge Eating Scale (BES) Score at Week 11(Baseline and week 11)
研究者
研究点 (29)
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