Effect of Levcromakalim in Individuals With Migraine Pretreated With Erenumab: A Randomized Double-Blind Placebo-Controlled Two-Way Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of migraine attack
研究概览
简要总结
An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intravenous infusion of levcromakalim (a potent vasodilator) induces cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
- •Age ≥18 years upon entry into screening.
- •History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
排除标准
- •History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
- •History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
- •Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
- •Prior intake of therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, and small molecule CGRP receptor antagonists.
- •The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
- •History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
- •Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- •Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
- •Evidence of current pregnancy or breastfeeding per participant self-report or medical records.
- •Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.
研究组 & 干预措施
Levcromakalim
干预措施: Levcromakalim (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of migraine attack
时间窗: 12 hours
Difference in incidence of migraine attack (0 to 12 hours) between levcromakalim and placebo. A migraine attack is defined as an 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 (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
次要结局
- Diameter of superficial temporal artery(1 hour)
- Intensity of headache(12 hours)
- Incidence of headache(12 hours)
研究者
Messoud Ashina, MD
Professor
Danish Headache Center