Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy; a Real World Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Change in monthly migraine days
研究概览
简要总结
Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy
详细描述
The investigators treated chronic migraineurs that have failed more than 3 preventive drugs with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine days, to evaluate If the add on of Erenumab to another preventive therapy is superior to Erenumab alone, and assess all adverse events related to the use of Erenumab.
Migraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic migraineurs with failure to more than 3 preventive treatments
- •Naive to anti CGRP monclonal antibodies
排除标准
- •episodic migraineurs,
- •Other headache types
研究组 & 干预措施
Reduction in monthly migraine days all cohorts at 4 months
Migraineurs with 15-30 headache days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly headache days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)
干预措施: Erenumab Auto-Injector (Drug)
Selection of elegible paitients
A total of 158 patients were involved in this study. 118 patients (75%), received Erenumab 140 mg., and 40 patients (25%) received 70 mg. In the Botox cohort, of 650 patients, 90 (13%) patients were eligible. In the no Botox cohort, 533 patients, 83 (15%) patients were eligible.
干预措施: Erenumab Auto-Injector (Drug)
Rate of adverse events related to Erenumab
72 adverse events were experienced during the 4 months of treatment, mostly with the 140 mg. dose. The most frequent were: constipation 34%, fatigue 19%, itching 7.5%, muscle cramps 6.3%, increased headache 4.4%, rhinitis 4.4%, injection site discomfort 3.7%, lack of energy 3.1%
干预措施: Erenumab Auto-Injector (Drug)
结局指标
主要结局
Change in monthly migraine days
时间窗: 5 months
Change in frequency of monthly migraine days
次要结局
- Change in frequency of monthly migraine days adding Erenumab to another preventive treatment,(5 months)
- Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment(5 months)
- change in frequency of monthly migraine days with Erenumab alone(5 months)
研究者
Guy Pierre Boudreau md
Medical Doctor, fellow in headache medecine
Clinique des Céphalées de Montréal