Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura
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Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura. / Thomsen, Andreas Vinther; Al-Karagholi, Mohammad Al Mahdi; Hougaard, Anders; Ostrowski, Sisse Rye; Pedersen, Ole Birger; Hansen, Thomas Folkmann; Ashina, Messoud.
In: Cephalalgia : an international journal of headache, Vol. 44, No. 3, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura
AU - Thomsen, Andreas Vinther
AU - Al-Karagholi, Mohammad Al Mahdi
AU - Hougaard, Anders
AU - Ostrowski, Sisse Rye
AU - Pedersen, Ole Birger
AU - Hansen, Thomas Folkmann
AU - Ashina, Messoud
PY - 2024
Y1 - 2024
N2 - 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. METHODS: 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. RESULTS: 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.
AB - 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. METHODS: 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. RESULTS: 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.
KW - experimental study
KW - Headache
KW - migraine
U2 - 10.1177/03331024241237247
DO - 10.1177/03331024241237247
M3 - Journal article
C2 - 38501895
AN - SCOPUS:85188424168
VL - 44
JO - Cephalalgia
JF - Cephalalgia
SN - 0800-1952
IS - 3
ER -
ID: 387255376