Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- changes on migraine severity during COVID-19 infection
研究概览
简要总结
The objective of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity
详细描述
Migraine is a debilitating disorder that affects 37 million people in the United States. Recently, three new injectables calcitonin gene-related peptide (CGRP) receptor antagonists-erenumab, fremanezumab, and galcanezumab-were FDA approved for prophylactic treatment of migraine in adults, that plays a key role in migraine pathophysiology. By blocking the receptor function of CGRP, these agents can reduce the total number of headache days per month and limit the need for using multiple medications. In clinical trials, these agents, which have no drug interactions and minimal adverse reactions, reduced headache days per month by as much as 50% in patients experiencing multiple migraine days each month. These new biologics, however, are more expensive for the patient compared with other prophylactic treatments
The rational of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
- •Sexes Eligible for Study: All
- •History of at least 5 attacks of migraine
- •≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
- •chronic migraineurs with failure to more than 2 preventive treatments
- •chronic migraineurs without any preventive treatments
- •Naive to anti CGRP monclonal antibodies
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
- •History of cluster or hemiplegic headache
- •Evidence of seizure or major psychiatric disorder Cardiac or active hepatic disease
- •pregnant, actively trying to become pregnant, or breast-feeding;
- •episodic migraineurs,
- •Other headache types
- •allergy to latex;
- •received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
- •prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
- •a psychiatric condition, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study
结局指标
主要结局
changes on migraine severity during COVID-19 infection
时间窗: during the 6 months
measuring the severity of migraine attacks on a numerical scale
mean number of migraine days
时间窗: 6 months
The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month.
次要结局
- rate of using migraine medications(during the 6 months)
- reduction in migraine days(during the 6 months)
- assessment of migraine effect on physical activity(during the 6 months)
研究者
Marwa Kamal
Principle investigator
Fayoum University