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 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:

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 (Adult)
Sexes Eligible for Study:	All
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


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

Keywords provided by Danish Headache Center:


VIP PACAP CGRP Prostanoids

Additional relevant MeSH terms:


Sumatriptan Vasoconstrictor Agents 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 July 18, 2017

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