Danish Headache Center, Department of Neurology, Rigshospitalet - Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Cephalalgia. 2024 Mar;44(3):3331024241237247. doi: 10.1177/03331024241237247.
BACKGROUND/HYPOTHESIS: Experimental provocation studies have yielded important insights in migraine pathophysiology. Levcromakalim has been previously shown to induce migraine-like attacks with and without aura. In this study, we aim to further explore the migraine aura-inducing potential of levcromakalim.
In a double-blind, randomized, placebo-controlled cross-over study, 27 adult participants with migraine with aura received intravenous infusions of levcromakalim and saline. Headache, aura and associated symptoms were evaluated for 24 hours following administration of the study drug. The primary endpoint was occurrence of migraine-like attacks with or without aura in the 24-hour observation period.
Thirteen participants developed migraine-like attacks on the active day only (P = 0.0098), and four participants developed aura on the active day only (P = 0.68). The median time to onset of migraine-like headache was three hours, and the median time to onset of aura was 27.5 minutes.
CONCLUSION/INTERPRETATION: Our findings affirm the potent migraine-inducing effect of levcromakalim. We observed a lower induction-rate of migraine aura than previously reported. Further studies are warranted to identify predictors of migraine aura following levcromakalim.
CLINICALTRIALS.GOV IDENTIFIER: NCT04905654.
背景/假设：实验性激发研究为偏头痛病理生理学提供了重要的见解。Levcromakalim 先前已被证明可引起有或无先兆的偏头痛样发作。在这项研究中，我们旨在进一步探索 Levcromakalim 诱发偏头痛先兆的潜力。
在一项双盲、随机、安慰剂对照的交叉研究中，27 名有先兆偏头痛的成年参与者接受了静脉输注 Levcromakalim 和生理盐水。给药后 24 小时内评估头痛、先兆和相关症状。主要终点是在 24 小时观察期内是否出现有或无先兆的偏头痛样发作。
13 名参与者仅在活跃日出现偏头痛样发作（P=0.0098），4 名参与者仅在活跃日出现先兆（P=0.68）。偏头痛样头痛的中位发作时间为 3 小时，先兆的中位发作时间为 27.5 分钟。
结论/解释：我们的发现证实了 Levcromakalim 对偏头痛的强烈诱发作用。我们观察到偏头痛先兆的诱导率低于先前报道。需要进一步研究以确定 Levcromakalim 后偏头痛先兆的预测因素。
临床试验.gov 标识符：NCT04905654。
