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Completed

NCT Number: NCT00957983

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

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

Completed

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Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BGC20-1531

Drug

oral administration followed by Prostaglandin E2 infusion

Other names: EP-4 receptor antagonist

Primary outcomes

  1. Headache

    Time frame: 24 hours

Secondary outcomes

  1. rCBF, blood flow, diameter of STA/RA, HR, BP

    Time frame: in-hospital

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2009
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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