The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

Study Overview
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Brief Summary
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To investigate the hemodynamic effects of CGRP after glibenclamide administration.

Detailed Description
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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.

Official Title
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The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

Conditions
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Hemodynamics of Cranial Arteries, Headache, Cerebral Blood Flow

Intervention / Treatment
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* Drug: glibenclamide
* Drug: CGRP infusion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGRP and glibenclamide<br>Participants will recieve CGRP infusion after glibenclamide/placebo administration | Drug: glibenclamide<br>* Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .<br>Drug: CGRP infusion<br>* CGRP infusion<br>|
| Active Comparator: CGRP and placebo<br>Participants will recieve CGRP infusion after glibenclamide/placebo administration | Drug: CGRP infusion<br>* CGRP infusion<br>Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |