A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- Reduction of Total Tsui Score at 4 Weeks From Baseline
研究概览
简要总结
- to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
- double blind, randomised, multi center, crossover study
详细描述
- Prospective, randomized, head-to-head, double-blind, cross-over study.
- Total patients: A group 51, B group 51
- Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
- Compare the TSUI change score from baseline to 4 weeks after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age of both genders,
- •Cervical dystonia
- •symptoms with a minimum duration of 18 months,
- •Negative pregnancy test in sexually active women,
- •Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).
排除标准
- •Patient with cervical contractures
- •Known significant underlying dysphasia
- •Patients who have received botulinum toxin treatment within the past 4 months.
- •Contraindication to botulinum toxin treatment
- •Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS ...)
- •Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,
- •Patients who required more than 500 units of Dysport or 200 units of Botox.
- •Any concomitant treatment that could interfere with the action of botulinum toxin,
- •Subjects having participated within the last 3 months or currently participating in an investigational drug study,
- •Pregnancy,
- •Lactation.
研究组 & 干预措施
Dysport® to Botox®
Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
干预措施: Dysport® (abobotulinumtoxinA) (Drug)
Dysport® to Botox®
Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
干预措施: Botox® (onabotulinumtoxinA) (Drug)
Botox® to Dysport®
Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
干预措施: Dysport® (abobotulinumtoxinA) (Drug)
Botox® to Dysport®
Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
干预措施: Botox® (onabotulinumtoxinA) (Drug)
结局指标
主要结局
Reduction of Total Tsui Score at 4 Weeks From Baseline
时间窗: 4 weeks after injection from baseline
Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor. Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.
次要结局
- CGI-I (Clinical Global Impression of Illness)(4, 8, 12 and 16 weeks after injection)
- PGI-I (Patient's Global Impression of Improvement)(4, 8, 12 and 16 weeks after injection)
- Reduction of Total TWSTRS Score at 4 Weeks From Baseline(4 weeks after injection from baseline)
研究者
BS Jeon
Professor
Seoul National University Hospital