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:	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:

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
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 February 09, 2012