Neuropeptides in the Humane Intra- og Extracerebral Circulation. - Full Text View

Sponsor:	Danish Headache Center
Collaborators:	Glostrup University Hospital, Copenhagen Bispebjerg Hospital
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00399633

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:	Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Sumatriptan Sumatriptan succinate

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, Copenhagen
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

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

Keywords provided by Danish Headache Center:

VIP
PACAP
CGRP
Prostanoids

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents

Brain Diseases
Pharmacologic Actions
Headache Disorders
Sumatriptan
Serotonin Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on February 09, 2010