NCT02009163已完成3 期
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy 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
- 418
- 试验地点
- 50
- 主要终点
- Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period
研究概览
简要总结
To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, 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 and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.
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
- •Subject is between 18-55 years of age, inclusive.
- •Subject meets the following criteria for a diagnosis of BED:
- •Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).
- •The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
- •Marked distress regarding binge eating.
- •The binge eating occurs, on average, at least 2 days a week for 6 months.
- •The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
- •Subject is consistently able to swallow a capsule.
排除标准
- •Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
- •Subject is receiving psychotherapy or weight loss support within the past 3 months.
- •Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
- •Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
- •Subject has abnormal thyroid function.
- •Subject initiated treatment with a lipid lowering medication within the past 3 months.
- •Subject has a history of moderate or severe hypertension.
- •Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
- •Subject has glaucoma.
- •Subject is female and pregnant or nursing.
- •Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
研究组 & 干预措施
Placebo
Placebo Comparator
Administer one capsule orally daily at approximately 7:00 AM.
干预措施: Placebo (Other)
Lisdexamfetamine dimesylate
Experimental
Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM.
干预措施: Lisdexamfetamine dimesylate (Drug)
结局指标
主要结局
Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period
时间窗: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).
次要结局
- Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period(Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period(Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination))
- Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period(Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]))
- Percent of Participants Within Each Category of The EuroQuol Group 5--Dimension 5--Level Self--Report Questionnaire (EQ--5D--5L) For Mobility at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period(Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period(Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period(Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period(Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination))
- Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period(Visit 8 (12 weeks after start of open-label treatment [Week 12]))
- Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period(Visit 21 (26 weeks after randomization [Week 38] or Early Termination))
- Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up(Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose))
研究者
研究点 (50)
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