A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine
A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE
Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.
The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Pfizer CT.gov Call Center
- 电话号码：1-800-718-1021
- 邮箱：ClinicalTrials.gov_Inquiries@pfizer.com
学习地点
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Tel Aviv、以色列、6423906
- 尚未招聘
- Sourasky Medical Center
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Jerusalem
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Jerusalem、Jerusalem、以色列、9103102
- 尚未招聘
- Shaare Zedek Medical Center
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California
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Canoga Park、California、美国、91303
- 招聘中
- Hope Clinical Research
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Los Angeles、California、美国、90048
- 招聘中
- Clinical Research Institute
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Florida
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Boca Raton、Florida、美国、33428
- 招聘中
- Neurology Offices of South Florida
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Miami、Florida、美国、33176
- 招聘中
- Brainstorm Research
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Orlando、Florida、美国、32801
- 招聘中
- Clinical Neuroscience Solutions
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Massachusetts
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Worcester、Massachusetts、美国、01609
- 招聘中
- New England Regional Headache Center
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Michigan
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Ann Arbor、Michigan、美国、48104
- 招聘中
- Michigan Headache & Neurological Institute
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Mississippi
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Ridgeland、Mississippi、美国、39157
- 招聘中
- Proven Endpoints, LLC
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North Carolina
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Greensboro、North Carolina、美国、27405
- 招聘中
- Headache Wellness Center
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Texas
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Austin、Texas、美国、78731
- 招聘中
- FutureSearch Trials of Neurology
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Dallas、Texas、美国、75251
- 招聘中
- FutureSearch Trials of Dallas
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Virginia
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McLean、Virginia、美国、22101
- 尚未招聘
- MedStar Health - Department of Neurology
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion:
- Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition
- Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) <15 monthly headache days (MHDs) (migraine or non-migraine); and (3) <7 monthly non-migraine headache days.
Exclusion:
- Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Rimegepant
Participants will receive rimegepant 75 mg ODT to administer for the acute treatment of migraine attacks of moderate or severe headache pain intensity. A second rimegepant 75 mg ODT should be taken in the event that participants are not pain free at approximately 2 hours post initial dose OR upon headache relapse after initial pain freedom. The second dose should be taken within 24 hours of the initial dose. Participants will receive rimegepant over a 24 week period during the OLT phase. Participants may redose with rimegepant up to a maximum of 10 times per month (28 days) during the OLT phase. |
刺身裤
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of Treatment-Emergent Adverse Events (TEAEs), serious TEAEs, and TEAEs leading to study intervention discontinuation on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall
大体时间：Up to 6 months
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Up to 6 months
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Incidence of LFT elevations, AST >3x ULN, alanine aminotransferase ALT >3x ULN, and total bilirubin >2x ULN on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall
大体时间：Up to 6 months
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Up to 6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Percentage of rimegepant-redosed headache days with satisfaction with headache pain reduction over the entire OLT phase, based on a rating of 'Extremely satisfied' or 'Satisfied' for satisfaction with study intervention to reduce headache pain
大体时间：Up to 6 months
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Up to 6 months
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Percentage of rimegepant-redosed headache days with reduced impact on daily activities over the entire OLT phase, based on a rating of 'Very good' or 'Good' for the ability of study intervention to reduce the impact of headaches on daily activities
大体时间：Up to 6 months
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Up to 6 months
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合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- C4951086
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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