Back to resultsEP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
Primary Purpose
Headache, Migraine
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
BGC20-1531
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Migraine
Eligibility 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)
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
BGC20-1531 200mg
sugar pill
BGC20-1531 400mg
Arm Description
Outcomes
Primary Outcome Measures
Headache
Secondary Outcome Measures
rCBF, blood flow, diameter of STA/RA, HR, BP
Full Information
NCT ID
NCT00957983
First Posted
August 12, 2009
Last Updated
January 10, 2011
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT00957983
Brief Title
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
Official Title
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGC20-1531 200mg
Arm Type
Active Comparator
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Title
BGC20-1531 400mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BGC20-1531
Other Intervention Name(s)
EP-4 receptor antagonist
Intervention Description
oral administration followed by Prostaglandin E2 infusion
Primary Outcome Measure Information:
Title
Headache
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
rCBF, blood flow, diameter of STA/RA, HR, BP
Time Frame
in-hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD, PhD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
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