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...
Date First Received: November 14, 2006
Last Updated: May 13, 2008
Verified by: Danish Headache Center, May 2008
Clinical Trial Phase: N/A | Start Date: January 2007
Overall Status: Completed
Estimated Enrollment: 16
Brief Summary
Official Title: “Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.”
Intervention(s):
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.
Study Type: Interventional
Study Design: Other, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Study Primary Completion Date: April 2007
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: sumatriptan
Outcome Measures for this Clinical Trial
Primary 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.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Danish Headache Center
Overall Clinical Trial Officials and Contacts
Jakob Møller Hansen, MD Principal Investigator Danish Headache Center
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00399633
Study ID Number: Neuropeptide2007
ClinicalTrials.gov Identifier: NCT00399633
Health Authority: Denmark: Ethics Committee
Clinical Trials Authorship and Review
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