A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Allergan
- 主要终点
- Percentage of Participants with AEs Leading to Discontinuation
研究概览
简要总结
This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has successfully completed the double-blind study (1313-301-008).
排除标准
- •Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
- •Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
- •Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
结局指标
主要结局
Percentage of Participants with AEs Leading to Discontinuation
时间窗: 24 Weeks
Change from Baseline in Vital Signs
时间窗: Baseline, Week 24
Vital signs include blood pressure and pulse.
Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters
时间窗: Baseline, Week 24
A standard 12-lead ECG will be performed at Baseline and Week 24.
Number of Participants with Adverse Events (AEs)
时间窗: 24 Weeks
An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Change from Baseline in Clinical Laboratory Parameters
时间窗: Baseline, Week 24
Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters.
次要结局
- Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period(Baseline, Weeks 12 and 24)
- Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24(Baseline, Weeks 12 and 24)