A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 282
- 试验地点
- 32
- 主要终点
- Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
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
- 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
- •History of chronic migraine
- •More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
排除标准
- •Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- •Previous treatment with botulinum toxin of any serotype for any reason
- •Previous treatment with topiramate
- •On a ketogenic diet (high in fat, low in carbohydrates)
- •History of acute myopia or increased intraocular pressure
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- •Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
研究组 & 干预措施
BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
干预措施: onabotulinumtoxinA (Biological)
Topiramate
Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.
干预措施: Topiramate (Drug)
结局指标
主要结局
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
时间窗: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
次要结局
- Change From Baseline in the Frequency of Headache Days Per 28-day Period(Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32)
- Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days(Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32)
- Change From Baseline in Headache Impact Test (HIT-6) Total Score(Baseline (Day 1) to the last 28-day period ending with Week 30)