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Neuropeptides in the Humane Intra- og Extracerebral Circulation.

This study has been completed.
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
Bispebjerg Hospital
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00399633
First received: November 14, 2006
Last updated: May 13, 2008
Last verified: May 2008
History of Changes
  Purpose

The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.


Condition Intervention
Healthy
Migraine
 Drug: sumatriptan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Blood concentration of vasoactive intestinal polypeptide (VIP),
  • calcitonin gene-related protein (CGRP), pituitary adenylate cyclase
  • activating peptide (PACAP,) and the prostanoids
  • 6-keto-PGF1α, PGE2, PGD2 and PGF2α, sampled from different
  • venous catheters.

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The study is meant to give a better understanding of the basic mechanisms behind migraine, and a better understanding of the effects of sumatriptan on the trigemino vascular system.

The endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • 18-50 years,
  • 50-100 kg.
  • Fertile women must use birth control.

Exclusion Criteria:

  • All primary types of headache
  • Daily intake of medicine except birth control
  • Pregnancy
  • Hypertension
  • Hypotension
  • other chronic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399633

Locations
Denmark
Danish Headache Center
Glostrup, Copenhagen, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Glostrup University Hospital, Copenhagen
Bispebjerg Hospital
Investigators
Principal Investigator: Jakob Møller Hansen, MD Danish Headache Center
  More Information

Additional Information:
The homepage of the Danish Headache Center  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00399633     History of Changes
Other Study ID Numbers: Neuropeptide2007
Study First Received: November 14, 2006
Last Updated: May 13, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
VIP
PACAP
CGRP
Prostanoids

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013