NCT01655862已完成不适用
Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 62
- 试验地点
- 8
- 主要终点
- Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
研究概览
简要总结
This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician
排除标准
- •Participation in a clinical trial for any botulinum toxin indication
- •Planning elective surgery during the observational study period
- •Treatment with any botulinum toxin product for cervical dystonia (dystonie)
- •Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start
结局指标
主要结局
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
时间窗: Baseline, 96 Weeks
次要结局
- Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score(Baseline, 96 Weeks)
- Work Productivity Assessment Using a 10-Item Questionnaire(96 Weeks)
- Patient's Global Impression of Change (PGIC) Using a 7-Point Scale(Baseline, 96 Weeks)
- Reasons for Withdrawal of Treatment(96 Weeks)
研究者
研究点 (8)
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