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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 14, 2014