Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danish Headache Center
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Blood concentration of vasoactive intestinal polypeptide (VIP),
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported