EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
Phase 1
Completed
- Conditions
- Headache, Migraine
- Interventions
- Drug: BGC20-1531
- Registration Number
- NCT00957983
- Lead Sponsor
- Danish Headache Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BGC20-1531 200mg BGC20-1531 - sugar pill BGC20-1531 - BGC20-1531 400mg BGC20-1531 -
- Primary Outcome Measures
Name Time Method Headache 24 hours
- Secondary Outcome Measures
Name Time Method rCBF, blood flow, diameter of STA/RA, HR, BP in-hospital
Trial Locations
- Locations (1)
Danish Headache Center
🇩🇰Glostrup, Denmark