The Hemodynamics Effect of Glibenclamide on Levcromakalim Assessed by High Resolution Magnetic Resonance Angiography (MRA) Technique in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

Danish Headache Center15 enrolled

Overview

To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.

15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration. The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration. Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Hemodynamics of Cranial Arteries Headache Cerebral Blood Flow

Interventions

LevcromakalimDRUG

Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.

SalineDRUG

Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers of both sexes. * 18-60 years. * 50-100 kg. * Women of childbearing potential must use adequate contraception Exclusion Criteria: * A history of serious somatic disease * Migraine or any other type of headache (except episodic tension-type headache less than once a month) * Daily intake of any medication except contraceptives * Contraindications for MRI scan.

Locations (2)

Danish headache center

Glostrup Municipality, Copenhagen, Denmark

RECRUITING

Mohammad Al-Mahdi Al-Karagholi

København S, Danmark, Denmark

RECRUITING

Outcomes

Primary Outcomes

Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)

Repeated MRA measurements covering the diameter of MMA , STA and MCA before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)

Time frame: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion

Changes in Cerebral blood flow

Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes

Headache

Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).

Time frame: Time of headache measurements is from before (-10 min) and after (12 hours) glibenclamide administration.

Data from ClinicalTrials.gov

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