NCT05750446

Effect of Riocigaut on Migraine Attack Induction in People With Migraine

Riociguat (BAY 63-2521), a Stimulator of Soluble Guanylate Cyclase (sGC) - Migraine Induction in People With Migraine.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Migraine Without Aura

Interventions

Type	Name	Description
DRUG	Riociguat (BAY 63-2521)	A selective stimulator of soluble guanylate cyclase (sGC)
OTHER	Placebo	Placebo

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-03-01
• Last updated: 2024-07-12

Locations

1 site across 1 country: Denmark