NCT01718483已完成3 期
The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 383
- 试验地点
- 47
- 主要终点
- Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
研究概览
简要总结
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary
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)
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 (Lisdexamfetamine dimesylate)
Experimental
干预措施: SPD489 (Lisdexamfetamine dimesylate) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
时间窗: Baseline and Visit 8 (Weeks 11-12)
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
次要结局
- Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks(Baseline and Week 12/Early termination (ET))
- Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks(Baseline and Week 12/ET)
- Binge Eating Response(Week 12/ET)
- Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)(Baseline and Visit 8 (Weeks 11-12))
- Change From Baseline in Binge Eating Scale (BES) Score at Week 12(Baseline and Week 12)
- Percentage of Participants With a 4-Week Cessation From Binge Eating(Up to 12 weeks)
- Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks(Baseline and Week 12/ET)
- Percent Change From Baseline in Body Weight at Week 12(Baseline and Week 12)
- Change From Baseline in Eating Inventory Scores at Week 12(Baseline and Week 12)
- Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12(Baseline and Week 12)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility(Up to 12 weeks)
- Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores(Up to 12 weeks)
- Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12(Baseline and Week 12)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression(Up to 12 weeks)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care(Up to 12 weeks)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities(Up to 12 weeks)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort(Up to 12 weeks)
- Amphetamine Cessation Symptom Assessment (ACSA) Total Score(Up to 12 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 12 weeks)
研究者
研究点 (47)
Loading locations...
相似试验
已完成
3 期
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating DisorderBinge Eating DisorderNCT01718509Shire390
撤回
3 期
Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)ADHDNCT01274221Shire
终止
3 期
Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of SchizophreniaSchizophreniaNCT01738698Shire4
已完成
4 期
Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)ADHD Specifically With Executive Function ImpairmentNCT01101022Shire161
已完成
3 期
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17Attention Deficit Disorder With HyperactivityNCT00150618Shire324