The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

NCT04960657 | Completed

• 1 other identifier: H19065735
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Conditions

Migraine; Headache; Pain

Keywords

Glyburide; Physiological Effects of Drugs; Hypoglycemic Agents

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).

  Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.

Study Arms (2)

PACAP38 and glibenclamide

ACTIVE COMPARATOR

Participants will receive glibenclamide after PACAP38 infusion

Drug: glibenclamide; Drug: PACAP38

PACAP38 and placebo

ACTIVE COMPARATOR

Participants will receive placebo after PACAP38 infusion

Drug: glibenclamide; Drug: PACAP38

Interventions

glibenclamide DRUG

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

PACAP38 and glibenclamide; PACAP38 and placebo

PACAP38 DRUG

PACAP38 infusion

Also known as: Pituitary adenylate cyclase activating polypeptide-38

PACAP38 and glibenclamide; PACAP38 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 age must use adequate contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Copenhagen, Capital Region, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain

Interventions

Glyburide; Pituitary Adenylate Cyclase-Activating Polypeptide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Proteins; Nerve Tissue Proteins; Biological Factors

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: May 24, 2021
• First Posted: July 14, 2021
• Study Start: October 20, 2020
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)