Danish Headache Center
Copenhagen, 2600, Denmark
NCT Number: NCT05889442
An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intravenous infusion of levcromakalim (a potent vasodilator) induces cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2600, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous intravenous infusion of 20 mL levcromakalim (0.05 mg/min (50 μg/ mL) over 20 minutes
Continuous intravenous infusion of 20 mL isotonic saline over 20 minutes
Time frame: 12 hours
Difference in incidence of migraine attack (0 to 12 hours) between levcromakalim and placebo.
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 Headache Society criteria:
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 verbal 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: 12 hours
Difference in incidence of headache (0 to 12 hours) between levcromakalim and placebo.
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; 10 is the worst pain imaginable.
Time frame: 12 hours
Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between levcromakalim and placebo.
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; 10 is the worst pain imaginable.
Time frame: 1 hour
Diameter (mm) of superficial temporal artery is measured as a continuous outcome.
Danish Headache Center
Other
Effect of Levcromakalim in Individuals With Migraine Pretreated With Erenumab: A Randomized Double-Blind Placebo-Controlled Two-Way Crossover Trial
Acronym: COLLIDE
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