Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area under the curve of headache intensity
研究概览
简要总结
The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.
详细描述
Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.
The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind study.
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
- •Diagnosis of migraine according to the international classification of headache disorders version 3-beta
- •Subject has tried anti-CGRP antibodies for migraine
- •Women of childbearing potential are on safe contraception
排除标准
- •Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
- •Daily drug intake apart from contraceptives and preventive medication for migraine.
- •Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
- •Pregnant or breast-feeding women
- •Migraine on the study day or less than 48 hours before CGRP infusion.
- •A history of cardiovascular and/or cerebrovascular disease
- •Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg on study day.
- •Systolic blood pressure <90 mmHg and/or diastolic blood pressure < 50 mmHg on study day.
- •A history of mental illness
- •A history of any illness or condition that is deemed relevant for participation by the investigator.
研究组 & 干预措施
Placebo
Infusion with placebo (isotonic saline)
干预措施: Placebo (Other)
Calcitonin gene-related peptide
Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)
干预措施: Calcitonin Gene-Related Peptide (Drug)
结局指标
主要结局
Area under the curve of headache intensity
时间窗: From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion
Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion
Incidence of migraine
时间窗: From 0 to 12 hours after CGRP infusion
Incidence of migraine after CGRP infusion
次要结局
- Heart rate(From 0 to 90 minutes after infusion)
- Blood pressure(From 0 to 90 minutes after infusion)
研究者
Casper Emil Christensen
MD, PhD student
Danish Headache Center