Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 26
- 主要终点
- Change in Monthly Headache Days and Monthly Migraine Days
研究概览
简要总结
The goal of this observational study is to evaluate clinical differences in patients who received preventive treatment with medication targeting calcitonin gene-related peptide (CGRP) or its receptor: monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) during a 2-year period observation phase.
详细描述
It is a 2-year, multicenter observational study. Patients who meet reimbursement criteria according to local regulations and willing to participate in the study will be included. Monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) will be started and baseline assessment will be conducted. There will be visits every 6 months to assess effectiveness, side-effects, PROMs, and elegibility to continue with the study drug. The observation of patients will last 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 diagnosis according to ICHD-III.
- •Prescription of erenumab, galcanezumab, fremanezumab, eptinezumab, atogepant or rimegepant according to prescriptor criteria and reimbursement criteria according to local regulations.
- •Signature of informed consent.
排除标准
- •Presence of headache different from migraine.
- •Active severe psychiatric condition or cognitive impairment which may affect the ability to consent patient's participation in the study.
研究组 & 干预措施
Migraine Patients
Migraine patients who initiate a CGRP-targeted treatment
干预措施: CGRP antibody or gepant (Drug)
结局指标
主要结局
Change in Monthly Headache Days and Monthly Migraine Days
时间窗: Through study completion, an average of 2 years
次要结局
- HIT-6(Through study completion, an average of 2 years)
- MIDAS(Through study completion, an average of 2 years)
- PGIC(Through study completion, an average of 2 years.)
- BAI(Through study completion, an average of 2 years.)
- BDI-II(Through study completion, an average of 2 years.)
- MSQ Version 2.1(Through study completion, an average of 2 years.)
- WPAI(Through study completion, an average of 2 years.)
- ISI(Through study completion, an average of 2 years.)
- ASC-12(Through study completion, an average of 2 years.)
- m-TOQ(Through study completion, an average of 2 years.)