NCT00836017已完成不适用
CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy
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
- 1,046
- 主要终点
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
研究概览
简要总结
This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Cervical Dystonia
- •Candidate for botulinum toxin type A therapy
- •New to physician's practice, and/or new to botulinum toxin type A therapy, or has not been injected with botulinum toxin type A for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type A for cervical dystonia
- •Able to follow study instructions and complete study activities
排除标准
- •Patients undergoing elective surgery during the trial period
- •Females who are pregnant, nursing, or planning a pregnancy
- •History of poor cooperation or compliance with medical treatment or unreliability
- •Any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
结局指标
主要结局
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
时间窗: 4-6 weeks after treatment 3 (Up to 104.3 weeks)
TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.
次要结局
- Pain Numeric Rating Scale Score(Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks))
- Percentage of Participants With Cervical Dystonia (CD) Severity Mild(Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks))
- Percentage of Participants With Improvement in Clinicians Global Impression of Change(Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks))
- Percentage of Participants With Improvement in the Patient Global Impression of Change(Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks))
研究者
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