Back to resultsHemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs
Primary Purpose
Headache, Migraine, Vasoactive Intestinal Peptide
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vasoactive intestinal peptide
Sponsored by
About this trial
This is an interventional diagnostic trial for Headache focused on measuring Migraine, VIP, Transcranial Doppler, Headache
Eligibility Criteria
Inclusion Criteria: migraineurs Exclusion Criteria: cerebrovascular disorders, pregnancy, nursing
Sites / Locations
- Glostrup Hospital
Outcomes
Primary Outcome Measures
Headache
Intra- and extracranial vasodilation
Secondary Outcome Measures
arterial blood pressure
heart rate
Full Information
NCT ID
NCT00272896
First Posted
January 4, 2006
Last Updated
January 4, 2006
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT00272896
Brief Title
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs
Official Title
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide (VIP) in Migraineurs
Study Type
Interventional
2. Study Status
Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Headache Center
4. Oversight
5. Study Description
Brief Summary
We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters.
Detailed Description
We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters. The subjects were randomly allocated to the infusion of 8pmol/kg/min VIP or placebo (isotonic saline), duration 25min. Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmMCA), superficial temporal artery diameter, end-expiratory CO2 and vital signs were recorded at baseline and then every 10 min until 120 min after start of the infusion. The patients received a headache diary for the following 12 hours after infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Vasoactive Intestinal Peptide, Ultrasonography, Doppler, Transcranial
Keywords
Migraine, VIP, Transcranial Doppler, Headache
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vasoactive intestinal peptide
Primary Outcome Measure Information:
Title
Headache
Title
Intra- and extracranial vasodilation
Secondary Outcome Measure Information:
Title
arterial blood pressure
Title
heart rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
migraineurs
Exclusion Criteria:
cerebrovascular disorders, pregnancy, nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jes Olesen, MD, PhD
Organizational Affiliation
Danish Headache Center, Glostrup, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs
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