Danish Headache Center
Copenhagen, 2600, Denmark
NCT Number: NCT05889455
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 intake of sildenafil (a potent vasodilator) can induce 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
Oral administration of 100mg
Placebo
Time frame: 12 hours
Difference in incidence of migraine attack (0 to 12 hours) between sildenafil 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:
D. During headache at least one of the following:
(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 sildenafil 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 sildenafil 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.
Danish Headache Center
Other
Effect of Sildenafil in Individuals With Migraine Pretreated With Erenumab: A Randomized Double-Blind Placebo-Controlled Two-Way Crossover Trial
Acronym: COMPETE
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