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To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.
22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACAP38 and glibenclamide | Active Comparator | Participants will receive glibenclamide after PACAP38 infusion |
|
| PACAP38 and placebo | Active Comparator | Participants will receive placebo after PACAP38 infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glibenclamide | Drug | Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration . |
| 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 minutes) and up to 12 hours after PACAP38 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA). | Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm) | Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Copenhagen | Capital Region | 2600 | Denmark |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D010146 | Pain |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| D051219 | Pituitary Adenylate Cyclase-Activating Polypeptide |
| 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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| PACAP38 | Drug | PACAP38 infusion |
|
|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |