Neuropeptides in the Humane Intra- og Extracerebral Circulation.

Healthy Clinical Trial

Official title:

Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399633
• Other study ID #: Neuropeptide2007
• Status: Completed
• Phase: N/A
• First received: November 14, 2006
• Last updated: May 13, 2008
• Start date: January 2007
• Est. completion date: April 2007

Study information

• Verified date: May 2008
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Healthy
• Migraine

Intervention

Drug:
• sumatriptan

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup, Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Danish Headache Center	Bispebjerg Hospital, Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentration of vasoactive intestinal polypeptide (VIP),
Primary	calcitonin gene-related protein (CGRP), pituitary adenylate cyclase
Primary	activating peptide (PACAP,) and the prostanoids
Primary	6-keto-PGF1a, PGE2, PGD2 and PGF2a, sampled from different
Primary	venous catheters.