This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on migraine inducing properties in people with migraine.
The investigators believe that activation of sGC could play a role in migraine pathophysiology and propose that stimulation with riociguat causes migraine attacks in people with migraine. Twenty-one people with migraine are expected to be included. They will participate at a screening visit and, if eligible, on two separate study days, where participants, in a randomized cross-over fashion, will ingest either riociguat (active comparator arm) or placebo (placebo comparator arm), serving as their own controls. On the two separate study days the investigators will measure heart rate, blood pressure and register possible headache/migraine including associated symptoms until 2 hours after intake of riociguat or placebo. At home participants are expected to fill out a headache diary until 12 hours from intake of riociguat or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
22
A selective stimulator of soluble guanylate cyclase (sGC)
Placebo
Danish Headache Center
Copenhagen, Glostrup, Denmark
Difference in incidence of migraine attacks between riociguat and placebo during a 12-hour observational period after ingestion.
Data will be collected with a questionnaire.
Time frame: 0-12 hours
Difference in Area Under the Curve (AUC) values for median headache intensity scores (Numeric Rating Scale (NRS) from 0 to 10, where 0="no pain" versus 1-10="pain") between riociguat and placebo during a 12-hour observational period after ingestion.
Data will be collected with a questionnaire.
Time frame: 0-12 hours
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