Experimental Headache Induced by Vasoactive Intestinal Polypeptide

Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound Clinical Trial

Official title:

Experimental Headache Induced by Vasoactive Intestinal Polypeptide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255320
• Other study ID #: VIP-KASGlo2004
• Status: Completed
• Phase: N/A
• First received: November 16, 2005
• Last updated: December 7, 2005
• Start date: December 2003
• Est. completion date: June 2004

Study information

• Verified date: December 2003
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Den Centrale Videnskabsetiske Komité i Denmark
• Study type: Interventional

Clinical Trial Summary

We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters.

Description:

We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters. In a double-blind, placebo-controlled, crossover design, the subjects were randomly allocated to receive 8 pmol/kg/min VIP or placebo (isotonic saline) over 25 min. Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion. Single photon emission computerized tomography (SPECT) was performed at T-0, T20 and T60.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• migraine cerebrovascular disorders pregnancy

Study Design

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

Related Conditions & MeSH terms

• Headache
• Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound
• Migraine Disorders

Intervention

Drug:
• VIP

Locations

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

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 intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion.
Secondary	All subjects were asked to complete a headache diary every hour until 10 h after the discharge. The diary included headache characteristics and accompanying symptoms according to the International Headache Society (IHS 2004)