CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- CGRP induced migraine attacks in patients with high and low genetic load
研究概览
简要总结
The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).
详细描述
Migraine is a very prevalent neurological disorder with a strong genetic factor. The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). The functional consequences of these genetic loci in humans are yet unknown.
Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM), an autosomal dominant subtype of MA.
The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified. One of the genetic loci (rs13208321) is located in a gene (FHL5) that is associated with the regulation of cAMP-responsive elements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.
排除标准
- •Other primary headache
- •A history of cerebrovascular disease and other CNS- disease
- •A history suggesting ischaemic heart disease
- •Serious somatic and mental disease
- •Hypo- or hypertension
- •Abuse of alcohol or medicine (opioid analgesics).
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Migraine patients with high genetic load
CGRP intravenous infusion 1.5 microgram/min for 20 min
干预措施: CGRP (Drug)
Migraine patients with low genetic load
CGRP intravenous infusion 1.5 microgram/min for 20 min
干预措施: CGRP (Drug)
结局指标
主要结局
CGRP induced migraine attacks in patients with high and low genetic load
时间窗: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).
次要结局
- CGRP induced migraine attacks in patients with high and low genetic load(Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP)