jRCT2051240163招募中不适用
AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 主要终点
- Number of migraine days per month
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 12age old over 至 17age old under（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •At least a 6 month history of migraine (with or without aura)
- •15 or more headache days/month
- •8 or more migraine days/month
- •Migraine lasting 4-72 hours if untreated
排除标准
- •Exclusion Criteria:
- •Unrelenting headache
- •Current psychiatric condition uncontrolled or untreated
- •History of suicidal behavior or the subject is at risk of self-harm
- •History of alcohol abuse and/or illicit drug use
- •History of severe drug allergy
- •Use of more than one medication for migraine prevention/prophylaxis
- •Participation in another clinical trial at the same time
结局指标
主要结局
Number of migraine days per month
时间窗: 12 Weeks
-Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month
次要结局
- Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month(12 Weeks)
- Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month(12 Weeks)
- Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month(12 weeks)
- Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQLTM) total score(12 Weeks)
- Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month(12 Weeks)
- Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall(Up to 15 months)
- Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken(Up to 15 Months)
- Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score(12 Weeks)
研究者
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