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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 200
- 试验地点
- 270
- 主要终点
- Number of migraine days per month
研究概览
简要总结
The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.
Rimegepant is a tablet that dissolves when you put it on or under your tongue.
The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours
In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.
Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.
In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.
Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
研究组 & 干预措施
Placebo
A placebo does not have any medicine in it but looks just like the medicine being studied.
干预措施: Placebo (Drug)
Rimegepant
Experimental medicine under study
干预措施: Rimegepant (Drug)
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 (PedsQL™) 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)