Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine: A Randomized Double-Blind Two-Way Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of migraine attacks
研究概览
简要总结
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
详细描述
Opening of adenosine triphosphate-sensitive potassium (KATP) channels using Levcromakalim causes migraine attacks with and without aura in a high proportion of patients.
Sumatriptan has been shown to reverse Levcromakalim-induced dilation of the middle meningeal artery and headache in healthy volunteers, indicating that Sumatriptan can overturn the physiological effects of levcromakalim.
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
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 65 Years（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.
- •Any headache 48 hours prior to, or any migraine 72 hours prior to the start of the experiment on day 1 and
- •Daily consumption of any drug/medication other than oral contraception (birth control).
- •Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
- •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-Sumatriptan
20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of sumatriptan.
干预措施: Levcromakalim (Drug)
Levcromakalim-Sumatriptan
20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of sumatriptan.
干预措施: Sumatriptan (Drug)
Levcromakalim-Placebo
20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of saline.
干预措施: Levcromakalim (Drug)
Levcromakalim-Placebo
20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of saline.
干预措施: Saline (Drug)
结局指标
主要结局
Incidence of migraine attacks
时间窗: Assessed from baseline to 12 hours after infusion of levcromakalim.
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 Classification of Headache Disorders 3rd edition: 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 the numerical 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
- Incidence of adverse events(Assessed from baseline to 12 hours after infusion of levcromakalim.)
- Intensity of headache(Assessed from baseline to 12 hours after infusion of levcromakalim.)
- Diameter of superficial temporal artery (STA) assessed using high frequency ultrasound(Assessed from baseline to 2 hours after infusion of levcromakalim.)
- Incidence of headache(Assessed from baseline to 12 hours after infusion of levcromakalim.)
研究者
Messoud Ashina, MD
Principal investigator
Danish Headache Center