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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Danish Headache Center
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Glibenclamide and Levcromakalim
Participants will receive levcromakalim infusion after glibenclamide administration
Intervention: Levcromakalim (Drug)
Glibenclamide and Saline
Participants will receive placebo infusion after glibenclamide administration
Intervention: Saline (Drug)
Placebo
Participants will receive placebo infusion after placebo administration.
Intervention: Saline (Drug)
Levcromakalim and Glibenclamide
Participants will receive levcromakalim infusion before glibenclamide administration.
Intervention: Levcromakalim (Drug)
Levcromakalim and Placebo
Participants will receive levcromakalim infusion before placebo administration.
Intervention: Levcromakalim (Drug)
Levcromakalim and Placebo
Participants will receive levcromakalim infusion before placebo administration.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
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)
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).
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student
Danish Headache Center