Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean Number of Days of Decrease in Pain Level Using VAS
研究概览
简要总结
The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.
详细描述
Contact PI for study details
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 and older
- •Migraine for more than three months, that fail to respond to two or more major anti-migraine drug, meeting criteria of chronic migraine
排除标准
- •Age below 18
- •Pregnant or may become pregnant
- •Disease of neuromuscular junction or drugs that affect N-M junction
- •Allergy to Botox
- •Previous use of Botox for migraine by similar methodology
研究组 & 干预措施
Placebo
Subjects are randomized to receive Placebo which is inactive saline (sterile salt water solution). The Subjects are injected with a comparable amount of placebo solution (2cc-3cc) as received by those randomized to receive active study drug. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.
干预措施: Placebo (Other)
Botox
Subjects are randomized to receive Active study drug Botox (onobotulinumtoxinA). The Botox is prepare by diluting 100units of toxin /1cc Saline. The Subjects are injected with 200-300units of units of Botox which is 2cc-3cc of solution. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.
干预措施: Botox (Drug)
结局指标
主要结局
Mean Number of Days of Decrease in Pain Level Using VAS
时间窗: 4 weeks
Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.
次要结局
- Number of Participants Satisfied With Treatment(4 weeks)