NCT00301665已完成2 期
A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 138
- 试验地点
- 17
- 主要终点
- Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
- •Migraine attacks have been persisting for more than 1 year
- •2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
- •2 to 6 migraine attacks of at least moderate severity during the screening period
排除标准
- •Non-migraine headaches such as tension-type headaches
- •Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
- •Onset of migraine is after age of 50
- •Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse
结局指标
主要结局
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
时间窗: 3 months
次要结局
- Reduction of migraine medication consumption.(3 months)
- Improvement of quality of life.(3 months)
- Reduction of the intensity of the migraine attacks.(3 months)
- Reduction of duration of the migraine attacks.(3 months)
研究者
研究点 (17)
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