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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957983
First Posted: August 13, 2009
Last Update Posted: January 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Danish Headache Center
  Purpose
The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.

Condition Intervention Phase
Headache, Migraine Drug: BGC20-1531 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Headache [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • rCBF, blood flow, diameter of STA/RA, HR, BP [ Time Frame: in-hospital ]

Enrollment: 8
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BGC20-1531 200mg Drug: BGC20-1531
oral administration followed by Prostaglandin E2 infusion
Other Name: EP-4 receptor antagonist
Placebo Comparator: sugar pill Drug: BGC20-1531
oral administration followed by Prostaglandin E2 infusion
Other Name: EP-4 receptor antagonist
Active Comparator: BGC20-1531 400mg Drug: BGC20-1531
oral administration followed by Prostaglandin E2 infusion
Other Name: EP-4 receptor antagonist

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957983


Locations
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Messoud Ashina, MD, PhD Danish Headache Center
  More Information

Responsible Party: Messoud Ashina, PhD, dr.med, senior consulter, Danish Headache Center
ClinicalTrials.gov Identifier: NCT00957983     History of Changes
Other Study ID Numbers: BGC20-1531-04
First Submitted: August 12, 2009
First Posted: August 13, 2009
Last Update Posted: January 11, 2011
Last Verified: September 2009

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs