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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

Primary Purpose

Hemodynamics of Cranial Arteries, Headache, Cerebral Blood Flow

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levcromakalim
Saline
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemodynamics of Cranial Arteries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Danish headache centerRecruiting
  • Mohammad Al-Mahdi Al-KaragholiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Glibenclamide and Levcromakalim

Glibenclamide and Saline

Placebo

Levcromakalim and Glibenclamide

Levcromakalim and Placebo

Arm Description

Participants will receive levcromakalim infusion after glibenclamide administration

Participants will receive placebo infusion after glibenclamide administration

Participants will receive placebo infusion after placebo administration.

Participants will receive levcromakalim infusion before glibenclamide administration.

Participants will receive levcromakalim infusion before placebo administration.

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

Full Information

First Posted
March 19, 2019
Last Updated
July 1, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT03886922
Brief Title
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
Official Title
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
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamics of Cranial Arteries, Headache, Cerebral Blood Flow

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glibenclamide and Levcromakalim
Arm Type
Active Comparator
Arm Description
Participants will receive levcromakalim infusion after glibenclamide administration
Arm Title
Glibenclamide and Saline
Arm Type
Active Comparator
Arm Description
Participants will receive placebo infusion after glibenclamide administration
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Participants will receive placebo infusion after placebo administration.
Arm Title
Levcromakalim and Glibenclamide
Arm Type
Active Comparator
Arm Description
Participants will receive levcromakalim infusion before glibenclamide administration.
Arm Title
Levcromakalim and Placebo
Arm Type
Active Comparator
Arm Description
Participants will receive levcromakalim infusion before placebo administration.
Intervention Type
Drug
Intervention Name(s)
Levcromakalim
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Description
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
Title
Changes in Cerebral blood flow
Description
Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes
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
Title
Headache
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Danish headache center
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad A Al-Karagholi
Phone
31191647
Email
mahdi.alkaragholi@gmail.com
Facility Name
Mohammad Al-Mahdi Al-Karagholi
City
København S
State/Province
Danmark
ZIP/Postal Code
2300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad A Al-Karagholi
Phone
31191647
Email
mahdi.alkaragholi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32806954
Citation
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.
Results Reference
derived

Learn more about this trial

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

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