NCT00168428已完成3 期
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 705
- 试验地点
- 6
- 主要终点
- Change in Frequency of Headache Days
研究概览
简要总结
This is a 60 week study including a double-blind phase followed by an open-label phase.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frequent migraine (>=15 headache days per month)
- •>=4 distinct headache episodes lasting >=4 hours
- •>=50% of baseline headache days migraine/probable migraine days
排除标准
- •Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
- •Any medical condition that puts the patient at increased risk with exposure to BOTOX
- •Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
- •Use of prophylactic headache medication within 28 days prior to week -4
- •Unremitting headache lasting continuously throughout the 4-week baseline period
- •Known or suspected TMD
- •Diagnosis of fibromyalgia
- •Beck depression inventory score >24 at week-4
- •Psychiatric problems that may have interfered with study participation
结局指标
主要结局
Change in Frequency of Headache Days
时间窗: Baseline, Week 24
Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day \[00:00 to 23:59\] for which the patient reported \>= 4 continuous hours of headache.
次要结局
- Change in Frequency of Migraine/Probable Migraine Headache Days(Baseline, Week 24)
- Change in Total Cumulative Hours of Headache Occurring on Headache Days(Baseline, Week 24)
- Change in Frequency of Headache Episodes(Baseline, Week 24)
- Change in Frequency of Moderate/Severe Headache Days(Baseline, Week 24)
- Percentage of Patients With Severe HIT-6 Impact Category Scores(Week 24)
研究者
研究点 (6)
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