NCT01718509已完成3 期
The SPD489-344, 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
- 390
- 试验地点
- 43
- 主要终点
- Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans 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
详细描述
Not Required
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
- •The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
- •Subject is between 18-55 years of age.
- •Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
- •Subject has a BED diagnosis.
- •Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
- •Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.
排除标准
- •Subjects are excluded from the study if any of the following exclusion criteria are met:
- •Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
- •Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.
- •Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
- •Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- •Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
- •Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
- •Subject has a history of moderate or severe hypertension.
- •Subject is female and pregnant or nursing.
- •Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
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 Which Spans Weeks 11/12
时间窗: Baseline and Visit 8 Which Spans Weeks 11/12
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
次要结局
- Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks(Baseline and up to 12 weeks)
- Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12(Baseline and Visit 8 Which Spans Weeks 11/12)
- Percent Change From Baseline in Body Weight (kg) at Week 12(Baseline and week 12)
- Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks(Baseline and up to 12 weeks)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression(Up to 12 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 12 weeks)
- Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores(Up to 12 weeks)
- 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): Pain/Discomfort(Up to 12 weeks)
- Percent of Participants With a 4-Week Cessation From Binge Eating(Up to 12 weeks)
- Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks(Baseline and up to 12 weeks)
- Binge Eating Response(Up to 12 weeks)
- Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks(Baseline and up to 12 weeks)
- Change From Baseline in Eating Inventory Scores at Week 12(Baseline and week 12)
- Change From Baseline in Binge Eating Scale (BES) Score at Week 12(Baseline and week 12)
- EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility(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)
- Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.(Baseline and Week 12)
研究者
研究点 (43)
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