Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs

Migraine Clinical Trial

Official title:

Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide (VIP) in Migraineurs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272896
• Other study ID #: KA04119
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: January 4, 2006
• Start date: October 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2004
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• migraineurs

Exclusion Criteria:

• cerebrovascular disorders, pregnancy, nursing

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Headache
• Migraine
• Ultrasonography, Doppler, Transcranial
• Vasoactive Intestinal Peptide

Intervention

Drug:
• Vasoactive intestinal peptide

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache
Primary	Intra- and extracranial vasodilation
Secondary	arterial blood pressure
Secondary	heart rate