A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 604
- 试验地点
- 81
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
研究概览
简要总结
To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Lisdexamfetamine dimesylate
干预措施: Lisdexamfetamine dimesylate (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
时间窗: 52 weeks
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: 53 weeks
Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "no," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.
次要结局
- Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale(Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination))
- Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort(End of Treatment (ET; either Visit 16 [Week 52] or Early Termination))
- Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility(End of Treatment (ET; either Visit 16 [Week 52] or Early Termination))
- Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care(End of Treatment (ET; either Visit 16 [Week 52] or Early Termination))
- Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities(End of Treatment (ET; either Visit 16 [Week 52] or Early Termination))
- Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression(End of Treatment (ET; either Visit 16 [Week 52] or Early Termination))
- Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)(Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination))