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

Not Applicable

• Conditions: Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow
• Interventions: Drug: Levcromakalim; Drug: Saline

• Registration Number: NCT03886922
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-04-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-07
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levcromakalim and Placebo	Saline	Participants will receive levcromakalim infusion before placebo administration.
Glibenclamide and Saline	Saline	Participants will receive placebo infusion after glibenclamide administration
Placebo	Saline	Participants will receive placebo infusion after placebo administration.
Levcromakalim and Glibenclamide	Levcromakalim	Participants will receive levcromakalim infusion before glibenclamide administration.
Glibenclamide and Levcromakalim	Levcromakalim	Participants will receive levcromakalim infusion after glibenclamide administration
Levcromakalim and Placebo	Levcromakalim	Participants will receive levcromakalim infusion before placebo administration.

Primary Outcome Measures

Name	Time	Method
Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)	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	Repeated MRA measurements covering the diameter of MMA , STA and MCA before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)
Headache	Time of headache measurements is from before (-10 min) and after (12 hours) glibenclamide administration.	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).
Changes in Cerebral blood flow	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	Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes

Trial Locations

Locations (2)

Mohammad Al-Mahdi Al-Karagholi; 🇩🇰 København S, Danmark, Denmark

Danish headache center; 🇩🇰 Glostrup, Copenhagen, Denmark