The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
Opening of adenosine triphosphate-sensitive potassium (KATP) channels using Levcromakalim causes migraine attacks with and without aura in a high proportion of patients. Sumatriptan has been shown to reverse Levcromakalim-induced dilation of the middle meningeal artery and headache in healthy volunteers, indicating that Sumatriptan can overturn the physiological effects of levcromakalim. The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
24
20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo.
10 min infusion of 4 mg sumatriptan.
10 min infusion of isotonic saline (placebo).
Danish Headache Centre
Glostrup, Region Sjælland, Denmark
Incidence of migraine attacks
A migraine attack is defined as an attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification of Headache Disorders 3rd edition: C. Headache has at least two of the following characteristics: * unilateral location * pulsating quality * moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on the numerical rating scale) * aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase) D. During headache at least one of the following: * nausea and/or vomiting * photophobia and phonophobia (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
Incidence of headache
Incidence of headache is defined as headache intensity ≥1 as measured by a numerical rating scale (NRS) from 0 to 10. It is a verbally declared scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
Intensity of headache
Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
Diameter of superficial temporal artery (STA) assessed using high frequency ultrasound
Diameter (mm) of superficial temporal artery (STA) is measured as a continuous outcome using high frequency ultrasound (Dermascan C, Cortex Technology, Denmark).
Time frame: Assessed from baseline to 2 hours after infusion of levcromakalim.
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Incidence of adverse events
Participants are instructed to inform the investigators in the case of adverse events.
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.