NCT01314365已完成不适用
DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 350
- 试验地点
- 45
- 主要终点
- Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score
研究概览
简要总结
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of idiopathic CD as determined by the enrolling investigator
- •If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study
- •Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews)
- •Provision of written informed consent prior to enrollment
排除标准
- •Contraindications to treatment with any BoNT-A or BoNT-B preparations
- •Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction
- •Anticipated concomitant treatment with BoNT for other than cervical dystonia
- •Secondary cervical dystonia
结局指标
主要结局
Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score
时间窗: Cycle 1 - Baseline and week 4
Patient Global Impression of Change using the 7-point Likert scale
时间窗: Cycle 1 - Baseline and week 4
次要结局
- Clinical Global Impression of Change using the 7-point Likert scale(Cycle 1 - Week 4 and early termination visit)
- Patient Global Impression of Change using the 7-point Likert scale(Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits)
- Time to Waning Effect of Dysport treatment/symptom re-emergence(Cycles 1 to 4 - Week 8 and at study termination visits)
- Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)(Cycles 1 & 3: Baseline)
- Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)(Cycles 1 to 4 - Baseline, week 4 and at study termination visits)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit)
研究者
研究点 (45)
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