Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 242
- 主要终点
- Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
研究概览
简要总结
Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cervical dystonia
排除标准
- •Current or previous botulinum toxin treatment of any type for any condition
研究组 & 干预措施
botulinum toxin Type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
干预措施: botulinum toxin type A (Biological)
botulinum toxin Type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
干预措施: botulinum toxin type A Formulation 2 (Biological)
Placebo (Normal Saline) / botulinum toxin Type A
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
干预措施: botulinum toxin type A (Biological)
Placebo (Normal Saline) / botulinum toxin Type A
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
干预措施: Normal Saline (Drug)
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
干预措施: botulinum toxin type A Formulation 2 (Biological)
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
时间窗: Baseline, Week 4
Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The 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 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. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.
次要结局
- Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1(Week 4)
- Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1(Week 4)
- Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1(Baseline, Week 4)
- Duration of Treatment Effect for Treatment Responders(Up to 6 Months)