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Experimental Headache Induced by Vasoactive Intestinal Polypeptide

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
VIP
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound focused on measuring healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - healthy volunteers Exclusion Criteria: - migraine cerebrovascular disorders pregnancy

Sites / Locations

  • Danish Headache Center , KAS Glostrup

Outcomes

Primary Outcome Measures

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 Outcome Measures

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)

Full Information

First Posted
November 16, 2005
Last Updated
December 7, 2005
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT00255320
Brief Title
Experimental Headache Induced by Vasoactive Intestinal Polypeptide
Official Title
Experimental Headache Induced by Vasoactive Intestinal Polypeptide
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound
Keywords
healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound

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)
VIP
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - healthy volunteers Exclusion Criteria: - migraine cerebrovascular disorders pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Møller Hansen, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Study Chair
Facility Information:
Facility Name
Danish Headache Center , KAS Glostrup
City
Glostrup, Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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Experimental Headache Induced by Vasoactive Intestinal Polypeptide

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