Cerebral Blood Flow, Headache, Hemodynamics of Cranial Arteries
Conditions
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.
Interventions
DRUGLevcromakalim
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.
DRUGSaline
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.
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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). |
Countries
Denmark
Outcome results
None listed