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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00957983

Enrollment

Registered

2009-08-13

Start date

2009-08-31

Completion date

2010-02-28

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine

Brief summary

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

Interventions

DRUGBGC20-1531

oral administration followed by Prostaglandin E2 infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Headache	24 hours

Secondary

Measure	Time frame
rCBF, blood flow, diameter of STA/RA, HR, BP	in-hospital

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026