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

Not Applicable

Completed

• Conditions: Headache; Migraine; Vasoactive Intestinal Peptide; Ultrasonography, Doppler, Transcranial

• Registration Number: NCT00272896
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Status Verified: 2004-10
• Study Start: 2004-10
• Study Completion: 2005-09
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Last Update Submitted: 2006-01-04
• Study First Posted: 2006-01-09
• Last Update Posted: 2006-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• migraineurs

Exclusion Criteria

• cerebrovascular disorders, pregnancy, nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Headache
Intra- and extracranial vasodilation

Secondary Outcome Measures

Name	Time	Method
arterial blood pressure
heart rate

Trial Locations

Locations (1)

Glostrup Hospital; 🇩🇰 Glostrup, Denmark