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

NCT03886922 | Unknown DMC

• 1 other identifier: Glibenclamide H-18052188
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (3)

• 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 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

  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

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

Study Arms (5)

Glibenclamide and Levcromakalim

ACTIVE COMPARATOR

Participants will receive levcromakalim infusion after glibenclamide administration

Drug: Levcromakalim

Glibenclamide and Saline

ACTIVE COMPARATOR

Participants will receive placebo infusion after glibenclamide administration

Drug: Saline

Placebo

SHAM COMPARATOR

Participants will receive placebo infusion after placebo administration.

Drug: Saline

Levcromakalim and Glibenclamide

ACTIVE COMPARATOR

Participants will receive levcromakalim infusion before glibenclamide administration.

Drug: Levcromakalim

Levcromakalim and Placebo

ACTIVE COMPARATOR

Participants will receive levcromakalim infusion before placebo administration.

Drug: Levcromakalim; Drug: Saline

Interventions

Levcromakalim DRUG

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.

Glibenclamide and Levcromakalim; Levcromakalim and Glibenclamide; Levcromakalim and Placebo

Saline DRUG

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.

Glibenclamide and Saline; Levcromakalim and Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers of both sexes.
• years.
• kg.
• Women of childbearing potential must use adequate contraception

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (2)

Danish headache center

Glostrup Municipality, Copenhagen, 2600, Denmark

RECRUITING

Mohammad Al-Mahdi Al-Karagholi

København S, Danmark, 2300, Denmark

RECRUITING

Related Publications (1)

• Al-Karagholi MA, Ghanizada H, Kokoti L, Paulsen JS, Hansen JM, Ashina M. Effect of KATP channel blocker glibenclamide on levcromakalim-induced headache. Cephalalgia. 2020 Sep;40(10):1045-1054. doi: 10.1177/0333102420949863. Epub 2020 Aug 17.

  PMID: 32806954 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Cromakalim; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Model Details: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: April 1, 2019
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

DK (2)