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To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glibenclamide and Levcromakalim | Active Comparator | Participants will receive levcromakalim infusion after glibenclamide administration |
|
| Glibenclamide and Saline | Active Comparator | Participants will receive placebo infusion after glibenclamide administration |
|
| Placebo | Sham Comparator | Participants will receive placebo infusion after placebo administration. |
|
| Levcromakalim and Glibenclamide | Active Comparator | Participants will receive levcromakalim infusion before glibenclamide administration. |
|
| Levcromakalim and Placebo | Active Comparator | Participants will receive levcromakalim infusion before placebo administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish headache center | Recruiting | Glostrup Municipality | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32806954 | Derived | 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. |
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Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
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| 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. |
|
| Mohammad Al-Mahdi Al-Karagholi | Recruiting | København S | Danmark | 2300 | Denmark |
|
| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019806 | Cromakalim |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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