The Involvement of ATP Sensitive Potassium Channel in Migraine Aura and Migraine Pain.
NCT ID: NCT05565001
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-09-01
2023-07-31
Brief Summary
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* Opening of KATP channels causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways.
* Opening of KATP channels causes migraine aura by induction of CSD.
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Detailed Description
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Although the biological underpinnings of migraine pain are incompletely understood, signaling pathways have been identified that are putatively responsible for the genesis of migraine pain. Recent human experimental data have implicated opening of KATP channels in migraine pathogenesis. In two randomized controlled trials, it was demonstrated that intravenous infusion of levcromakalim - an opener of KATP channels - induced migraine pain in people with migraine with and without aura.
\- It remains unknown whether KATP channel opening causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways, as proposed during spontaneous migraine attacks.
Migraine Aura About one-third of people with migraine experience aura symptoms, which are characterized by reversible focal neurologic symptoms, typically comprising visual or hemisensory disturbances. The physiological substrate of the aura phase of migraine is thought to be cortical spreading depression (CSD), a self-propagating wave of depolarization across the cerebral cortex that disrupts ionic gradients and is followed by cerebral hypoperfusion. Recently, it was reported that intravenous infusion of levcromakalim - an opener of KATP channels - induced migraine aura in migraine with aura patients.
\- It remains unknown whether KATP channel opening causes CSD which leads to migraine aura, as observed during spontaneous migraine attacks.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Levcromakalim
Intravenous infusion of 1 mg levcromakalim followed by intravenous sumatriptan infusion.
Levcromakalim
Intravenous administration of levcromakalim or placebo over 20 minutes. After 3 hours from the administration of levcromakalim or placebo, participants will receive intravenous infusion of sumatriptan over 10 minutes.
placebo (isotonic saline)
Intravenous infusion of placebo (isotonic saline) followed by intravenous sumatriptan infusion.
Levcromakalim
Intravenous administration of levcromakalim or placebo over 20 minutes. After 3 hours from the administration of levcromakalim or placebo, participants will receive intravenous infusion of sumatriptan over 10 minutes.
Interventions
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Levcromakalim
Intravenous administration of levcromakalim or placebo over 20 minutes. After 3 hours from the administration of levcromakalim or placebo, participants will receive intravenous infusion of sumatriptan over 10 minutes.
Eligibility Criteria
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Inclusion Criteria
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception.
Exclusion Criteria
* Any other type of headache (except episodic tension-type headache less than once a month) Daily intake of any medication except contraceptives Contraindications for MRI scan.
18 Years
60 Years
ALL
No
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Mohammad Al-Mahdi Al-Karagholi
Study investigator
Locations
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Danish headache center
Copenhagen, Glostrup, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-21028500
Identifier Type: -
Identifier Source: org_study_id
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