EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

Danish Headache Center8 enrolled

Overview

The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Headache, Migraine

Interventions

BGC20-1531DRUG

oral administration followed by Prostaglandin E2 infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * Tension headache * All other primary forms of headache * Cardiovascular, Central Nervous system (CNS) and autoimmune diseases * Gastrointestinal disease * Previous or clinical signs of mental illness or substance abuse. * Participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial * Pregnancy/nursing * Daily intake of medication (except oral contraceptives)

Locations (1)

Danish Headache Center

Glostrup Municipality, Denmark

Outcomes

Primary Outcomes

Headache

Time frame: 24 hours

Secondary Outcomes

rCBF, blood flow, diameter of STA/RA, HR, BP

Time frame: in-hospital

Data from ClinicalTrials.gov

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