NCT05518123已完成4 期
A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 962
- 试验地点
- 220
- 主要终点
- Compare the efficacy of rimegepant (75 mg) to placebo
研究概览
简要总结
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- •Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
- •4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
- •Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
- •Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).
排除标准
- •History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
- •Current medication overuse headaches.
- •15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
- •Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
- •Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]).
- •Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Rimegepant 75 mg
Experimental
干预措施: Rimegepant (Drug)
结局指标
主要结局
Compare the efficacy of rimegepant (75 mg) to placebo
时间窗: Week 1 to 12 of DBT Phase
Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication.
次要结局
未报告次要终点
研究者
研究点 (220)
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