An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 502
- 主要终点
- Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
研究概览
简要总结
Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD).
详细描述
This is an open-label study aimed to assess long-term safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD). Up to 500 adult patients with a confirmed clinical diagnosis of CD are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study, patients will receive repeat injections of MYOBLOC every 12 weeks when deemed appropriate by the Investigator. Injections should not occur more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older
- •body weight of at least 46 kilograms
- •History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
排除标准
- •Inability to give informed consent
- •Patient who has been previously treated with botulinum Toxin Type B
- •Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
- •History of phenol injections involving the neck or shoulder region in the last 12 months.
- •Patients with neck contractures or cervical spine disease
结局指标
主要结局
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
时间窗: Session 1 - Time 0, 4 weeks post-injection compared to baseline
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
次要结局
- Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 2 (12 wks) - 4 weeks post-injection compared to baseline)
- Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 3 (24 Wks) - 4 weeks post-injection compared to baseline)
- Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 4 (36 Wks) - 4 weeks post-injection compared to baseline)
- Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 5 (48 Wks) - 4 weeks post-injection compared to baseline)
- Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 6 (60 Wks) - 4 weeks post-injection compared to baseline)
- Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 7 (72 Wks) - 4 weeks post-injection compared to baseline)
- Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms(Session 8 (84 Wks) - 4 weeks post-injection compared to baseline)