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To investigate the hemodynamic effects of CGRP after glibenclamide administration.
20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGRP and glibenclamide | Active Comparator | Participants will recieve CGRP infusion after glibenclamide/placebo administration |
|
| CGRP and placebo | Active Comparator | Participants will recieve CGRP infusion after glibenclamide/placebo administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glibenclamide | Drug | Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration . |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) | Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm) | Time of measurements is baseline and repeatedly every 20 min for 240 min. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (-20 min) and after (12 hours) glibenclamide/placebo administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish headache center | Glostrup Municipality | Copenhagen | 2600 | Denmark | ||
| Mohammad Al-Mahdi Al-Karagholi |
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| 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 |
|---|---|
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
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| CGRP infusion | Drug | CGRP infusion |
|
| Placebo | Drug | placebo |
|
| København S |
| Danmark |
| 2300 |
| Denmark |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |