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

Headache, Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957983
• Other study ID #: BGC20-1531-04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 12, 2009
• Last updated: January 10, 2011
• Start date: August 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2009
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Drug:
• BGC20-1531
oral administration followed by Prostaglandin E2 infusion

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache		24 hours	No
Secondary	rCBF, blood flow, diameter of STA/RA, HR, BP		in-hospital	Yes