Experimental Headache Induced by Vasoactive Intestinal Polypeptide
This study has been completed.
Sponsor:
Danish Headache Center
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00255320
First received: November 16, 2005
Last updated: December 7, 2005
Last verified: December 2003
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Purpose
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.
| Condition | Intervention |
|---|---|
| Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound | Drug: VIP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | Experimental Headache Induced by Vasoactive Intestinal Polypeptide |
Resource links provided by NLM:
Further study details as provided by Danish Headache Center:
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)
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | June 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- migraine cerebrovascular disorders pregnancy
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00255320
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255320
Locations
| Denmark | |
| Danish Headache Center , KAS Glostrup | |
| Glostrup, Copenhagen, Denmark, 2600 | |
Sponsors and Collaborators
Danish Headache Center
Investigators
| Study Chair: | Jakob Møller Hansen, MD | Danish Headache Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00255320 History of Changes |
| Other Study ID Numbers: |
VIP-KASGlo2004 |
| Study First Received: | November 16, 2005 |
| Last Updated: | December 7, 2005 |
Keywords provided by Danish Headache Center:
|
healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain |
Neurologic Manifestations Signs and Symptoms Vasoactive Intestinal Peptide Gastrointestinal Agents Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 18, 2017


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