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

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT00957983
Collaborator
(none)
8
Enrollment
1
Location
3
Arms
6
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BGC20-1531 200mg

Drug: BGC20-1531
oral administration followed by Prostaglandin E2 infusion
Other Names:
  • EP-4 receptor antagonist

    		•
    Placebo Comparator: sugar pill

    Drug: BGC20-1531
    oral administration followed by Prostaglandin E2 infusion
    Other Names:
  • EP-4 receptor antagonist

    		•
    Active Comparator: BGC20-1531 400mg

    Drug: BGC20-1531
    oral administration followed by Prostaglandin E2 infusion
    Other Names:
  • EP-4 receptor antagonist

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Headache [24 hours]

    Secondary Outcome Measures

    1. rCBF, blood flow, diameter of STA/RA, HR, BP [in-hospital]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danish Headache Center Glostrup Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    • Principal Investigator: Messoud Ashina, MD, PhD, Danish Headache Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00957983
    Other Study ID Numbers:
    • BGC20-1531-04
    First Posted:
    Aug 13, 2009
    Last Update Posted:
    Jan 11, 2011
    Last Verified:
    Sep 1, 2009
    Additional relevant MeSH terms:
    Migraine Disorders
    Headache

    Study Results

    No Results Posted as of Jan 11, 2011