The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Migraine-like attack
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
- •50-100 kg weight
- •Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
排除标准
- •Any other primary headache disorder according to the International Classification of Headache Disorders except for tension-type headache
- •Any secondary headache disorder according to the International Classification of Headache Disorders
- •Migraine attack during the preceding 48 hours on provocation day
- •Headache during the preceding 24 hours on provocation day
- •Treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year
- •Daily consumption of any other drug/medication than oral contraception (birth control)
- •Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception
- •Pregnant or active breastfeeding participants
- •Any cardiovascular diseases including cerebrovascular disorders
- •Information in patient history or during physical examination indicating psychiatric disorders or substance abuse
- •Information in patient history or during physical examination that the screening physician deems relevant for participation in the study
研究组 & 干预措施
Randomized treatment phase: Erenumab
Erenumab 140 mg single subcutaneous injection at baseline
干预措施: Erenumab (Drug)
Randomized treatment phase: Erenumab
Erenumab 140 mg single subcutaneous injection at baseline
干预措施: Calcitonin gene-related peptide (Drug)
Randomized treatment phase: Erenumab
Erenumab 140 mg single subcutaneous injection at baseline
干预措施: Cilostazol (Drug)
Randomized treatment phase: Placebo
Saline placebo single subcutaneous injection at baseline
干预措施: Placebo (Drug)
Randomized treatment phase: Placebo
Saline placebo single subcutaneous injection at baseline
干预措施: Calcitonin gene-related peptide (Drug)
Randomized treatment phase: Placebo
Saline placebo single subcutaneous injection at baseline
干预措施: Cilostazol (Drug)
Open-label extension treatment phase: Erenumab
Erenumab 140 mg monthly subcutaneous injection for six months after completion of the randomized, double-blinded, placebo-controlled study phase during the open-label extension
干预措施: Erenumab (Drug)
结局指标
主要结局
Migraine-like attack
时间窗: Before (-5 min) and after administration of (+12 hours) of experimental trigger
The incidence of migraine-like attack after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. A migraine-like attack is defined attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Headache Society criteria: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on verbal rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; and (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
次要结局
- Headache intensity(Before (-5 min) and after administration of (+12 hours) of experimental trigger)
- Hemodynamics (superficial temporal artery)(Before (-5 min) and after administration of (+90 minutes) of experimental trigger)
- Hemodynamics (radial artery)(Before (-5 min) and after administration of (+90 minutes) of experimental trigger)
- Neuropeptide plasma concentrations (CGRP)((1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase)
- Neuropeptide plasma concentrations (VIP)((1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase)
- Neuropeptide plasma concentrations (PACAP)((1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase)
- Facial flushing(Before (-5 min) and after administration of (+90 minutes) of experimental trigger)
- Facial temperature(Before (-5 min) and after administration of (+90 minutes) of experimental trigger)
- Headache day(Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase)
- Migraine day(Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase)
- ≥50% responder rate(Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase)
研究者
Messoud Ashina
Principal Investigator
Danish Headache Center