The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

NCT ID: NCT04960657

Last Updated: 2021-07-14

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-03-19

Brief Summary

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To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Detailed Description

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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

Conditions

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Migraine Headache Pain

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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PACAP38 and glibenclamide

Participants will receive glibenclamide after PACAP38 infusion

Group Type ACTIVE_COMPARATOR

glibenclamide

Intervention Type DRUG

Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .

PACAP38

Intervention Type DRUG

PACAP38 infusion

PACAP38 and placebo

Participants will receive placebo after PACAP38 infusion

Group Type ACTIVE_COMPARATOR

glibenclamide

Intervention Type DRUG

Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .

PACAP38

Intervention Type DRUG

PACAP38 infusion

Interventions

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glibenclamide

Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .

Intervention Type DRUG

PACAP38

PACAP38 infusion

Intervention Type DRUG

Other Intervention Names

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Pituitary adenylate cyclase activating polypeptide-38

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing age must use adequate contraception

Exclusion Criteria

* A history of serious somatic or psychiatric disease
* Migraine or any other type of headache (except episodic tension-type headache less than 5 days per 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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Lili Kokoti

MD, PhD student, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H19065735

Identifier Type: -

Identifier Source: org_study_id

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