The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

NCT04231617 | Completed DMC

• 1 other identifier: H-19065735
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

Conditions

Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Headache

  Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.

Study Arms (2)

CGRP and glibenclamide

ACTIVE COMPARATOR

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Drug: glibenclamide; Drug: CGRP infusion

CGRP and placebo

ACTIVE COMPARATOR

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Drug: CGRP infusion; Drug: Placebo

Interventions

glibenclamide DRUG

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

CGRP and glibenclamide

CGRP infusion DRUG

CGRP infusion

CGRP and glibenclamide; CGRP and placebo

Placebo DRUG

placebo

CGRP and placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers of both sexes.
• years.
• kg.
• Women of childbearing potential must use adequate contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (2)

Danish headache center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Mohammad Al-Mahdi Al-Karagholi

København S, Danmark, 2300, Denmark

Location

MeSH Terms

Conditions

Headache

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, Principal investigator

Model Details: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: January 20, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

DK (2)