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

Danish Headache Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Headache, Migraine

Treatments: Drug: BGC20-1531

Study type: Interventional

Funder types: Other

Identifiers

NCT00957983

BGC20-1531-04

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 3 patient groups, including a placebo group

BGC20-1531 200mg

Active Comparator group

Treatment:

Drug: BGC20-1531

sugar pill

Placebo Comparator group

Treatment:

Drug: BGC20-1531

BGC20-1531 400mg

Active Comparator group

Treatment:

Drug: BGC20-1531