NCT07301008招募中4 期
Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity
研究概览
简要总结
Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)
- •Men and women ≥ 18 years old .
- •Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
- •Headache/migraine onset before age 50 years
- •Migraine attacks, on average, lasting 4-72 hours if untreated
- •At least 48 hours between migraine attacks
- •Ability to distinguish migraine attacks from tension or cluster headaches
- •Particpants on SOC treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the course of the study
- •Participant may have been on treatment with Botox or mAbs for the last 6 months
- •Participants experience migraine ≥75% of the time following exposure to a trigger during the run-in period. Acceptable triggers include exercise, alcohol ( less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or weekend/ let-down
排除标准
- •Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment
- •History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening
- •Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.
- •Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
- •Women must not be pregnant, lactating or breastfeeding
研究组 & 干预措施
Rimegepant 75 MG
Experimental
干预措施: Rimegepant 75 MG (Drug)
结局指标
主要结局
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity
时间窗: 24 hour post dose
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity occurs within 24 hours
次要结局
- Percentage of preemptive treatments with rimegepant(24 hour, 48 hour post dose)
- Patient satisfaction with preemptive treatment with rimegepant(At the end of the study completion( 2 month after enrollment))
- The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC)(At the end of study completion( 2 months after enrollement))
研究者
研究点 (1)
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