Danish Headache Center, Department of Neurology, Rigshospitalet - Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Cephalalgia. 2024 Aug;44(8):3331024241274366. doi: 10.1177/03331024241274366.
BACKGROUND/HYPOTHESIS: Levcromakalim has previously been shown to induce attacks of migraine with aura in certain individuals. In this study, we tested the migraine-inducing effect of levcromakalim in a cohort of participants with migraine aura without headache.
In a double-blind, randomized, placebo-controlled cross-over study, eight adult participants with migraine with aura received intravenous infusions of levcromakalim and saline. Headache, aura and associated symptoms were evaluated for 24 h following administration of the study drug. The primary endpoint was occurrence of migraine-like attacks with or without aura in the 24-h observation period.
Five participants (62.5%) developed migraine of any type following levcromakalim compared with three participants (37.5%) following placebo. No participants developed aura following levcromakalim.
CONCLUSION/INTERPRETATION: Our findings suggest that the aura-inducing effect of levcromakalim is likely not based on direct induction of cortical spreading depression but may involve activation of the trigeminovascular system. This hypothesis should be further explored in future studies.
CLINICALTRIALS.GOV IDENTIFIER: NCT04905654.
背景/假设：Levcromakalim 先前已被证明在某些个体中会诱发有先兆的偏头痛发作。在这项研究中，我们在一组无头痛的有先兆偏头痛患者中测试了 Levcromakalim 的诱发偏头痛作用。
在一项双盲、随机、安慰剂对照的交叉研究中，8 名有先兆偏头痛的成年参与者接受了静脉内输注 Levcromakalim 和生理盐水。在给予研究药物后的 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伴有或不伴有先兆的偏头痛样发作。
与安慰剂组的 3 名参与者（37.5%）相比，Levcromakalim 组有 5 名参与者（62.5%）出现了任何类型的偏头痛。没有参与者在 Levcromakalim 组出现先兆。
结论/解释：我们的研究结果表明，Levcromakalim 的诱发先兆作用可能不是基于直接诱导皮质扩散性抑制，而是可能涉及三叉血管系统的激活。这一假设应在未来的研究中进一步探讨。
临床试验.gov 标识符：NCT04905654。
