A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Headache relief in 2 hours
研究概览
简要总结
Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.
详细描述
This is a phase IV, open-label, prospective, longitudinal clinical trial of intranasal zavegepant 10 mg, a CGRP receptor antagonist, for the acute treatment of migraine attacks amongst individuals who are concomitantly taking stable doses of CGRP targeting migraine preventive treatment (atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant). The effectiveness and tolerability of zavegepant will be assessed in this specific participant population. Participants who are not already taking a CGRP-targeting migraine preventive treatment but who meet criteria for migraine prevention according to their clinician's discretion, will have the option to start rimegepant 75 mg every other day (qod) for two months. After two months, continued eligibility for participation in the clinical trial of zavegepant will be assessed. Those receiving rimegepant for migraine prevention through their participation in this study will have the option to receive rimegepant for up to 32 consecutive weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report.
- •Exclusion Criteria
- •History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.
排除标准
- 未提供
研究组 & 干预措施
Zavegepant Treatment
Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.
干预措施: Zavegepant (Drug)
结局指标
主要结局
Headache relief in 2 hours
时间窗: 2 hours
Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant
Headache relief in 4 hours
时间窗: 4 hours
Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant
Functional disability level in 2 hours
时间窗: 2 hours
Percentage of participants with functional disability level of normal or mildly impaired within 2 hours of administering zavegepant.
Functional disability level in 4 hours
时间窗: 4 hours
Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant.
次要结局
- Adverse events(Approximately 24-32 weeks)
- Serious adverse events(Approximately 24-32 weeks)
- Discontinuation due to adverse events(Approximately 24-32 weeks)
研究者
Todd J. Schwedt
Principal Investigator
Mayo Clinic