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

Overview

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

Full Title of Study: “The Hemodynamics Effect of Levcromakalim After Glibenclamide Administration Assessed by High Resolution MRA Technique in a Randomized, Double-blind, Cross-over and Placebo-controlled Study With Healthy Volunteers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2020

Detailed Description

12 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days efter oral glibenclamide administration.

The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.

Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.

Interventions

  • Drug: Levcromakalim
    • 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.
  • Drug: Saline
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Glibenclamide and Levcromakalim
    • Participants will recieve levcromakalim/placebo infusion after glibenclamide administration
  • Active Comparator: Glibenclamide and Saline
    • Participants will receive levcromakalim/placebo infusion after glibenclamide administration
  • Sham Comparator: Saline
    • Participants will receive levcromakalim/placebo infusion after glibenclamide administration

Clinical Trial Outcome Measures

Primary Measures

  • Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
    • 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
    • Repeated MRA measurements covering the diameter of MMA , STA and MCA before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)
  • Changes in Cerebral blood flow
    • 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
    • Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes
  • Headache
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Danish Headache Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student – Danish Headache Center

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