The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

NCT ID: NCT04231617

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-09-01

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.

Conditions

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Hemodynamics of Cranial Arteries Headache Cerebral Blood Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CGRP and glibenclamide

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Group Type ACTIVE_COMPARATOR

glibenclamide

Intervention Type DRUG

Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .

CGRP infusion

Intervention Type DRUG

CGRP infusion

CGRP and placebo

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Group Type ACTIVE_COMPARATOR

CGRP infusion

Intervention Type DRUG

CGRP infusion

Placebo

Intervention Type DRUG

placebo

Interventions

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glibenclamide

Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .

Intervention Type DRUG

CGRP infusion

CGRP infusion

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Al-Mahdi Al-Karagholi

MD, PhD student, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish headache center

Glostrup Municipality, Copenhagen, Denmark

Site Status

Mohammad Al-Mahdi Al-Karagholi

København S, Danmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-19065735

Identifier Type: -

Identifier Source: org_study_id

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