open access publication

Article, 2024

Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura

Cephalalgia, ISSN 0333-1024, 1468-2982, Volume 44, 3, Page 03331024241237247, 10.1177/03331024241237247

Contributors

Thomsen, Andreas Vinther [1] Al-Karagholi, Mohammad Al-Mahdi 0000-0003-1118-9665 [1] Hougaard, Anders 0000-0003-0434-7426 [1] [2] Ostrowski, Sisse Rye 0000-0001-5288-3851 [1] [3] Pedersen, Ole Birger Vesterager 0000-0003-2312-5976 [1] [4] Hansen, Thomas Folkmann 0000-0001-6703-7762 [1] [2] Ashina, Messoud 0000-0003-0951-5804 (Corresponding author) [1] [5]

Affiliations

  1. [1] University of Copenhagen
    2. [NORA names: KU University of Copenhagen; University; Denmark; Europe, EU; Nordic; OECD];
  2. [2] Copenhagen University Hospital
    3. [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
  3. [3] Rigshospitalet
    4. [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
  4. [4] Zealand University Hospital
    5. [NORA names: Region Zealand; Hospital; Denmark; Europe, EU; Nordic; OECD];
  5. [5] Danish Knowledge Center on Headache Disorders, Glostrup, Denmark
    6. [NORA names: Miscellaneous; Denmark; Europe, EU; Nordic; OECD]

Abstract

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.

Keywords

activity days, administration, adult participants, associated symptoms, attacks, aura, cross-over study, days, double-blind, drug, effect, effects of levcromakalim, endpoint, findings, headache, hours, induce migraine-like attacks, intravenous infusion, investigation, levcromakalim, median time to onset, migraine, migraine aura, migraine pathophysiology, migraine-inducing effect, migraine-like attacks, migraine-like headache, observation period, occurrence, onset, participants, pathophysiology, patients, period, placebo-controlled cross-over study, predictors, primary endpoint, provocation studies, saline, study, study drug, symptoms, time to onset

Funders

  • Lundbeck Foundation
  • Capital Region of Denmark

Data Provider: Digital Science

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