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Sponsored by: |
Danish Headache Center |
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Information provided by: | Danish Headache Center |
ClinicalTrials.gov Identifier: | NCT00255320 |
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 |
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Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound |
Drug: VIP |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Experimental Headache Induced by Vasoactive Intestinal Polypeptide |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- migraine cerebrovascular disorders pregnancy
Study ID Numbers: | VIP-KASGlo2004 |
Study First Received: | November 16, 2005 |
Last Updated: | December 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00255320 History of Changes |
Health Authority: | Denmark: Den Centrale Videnskabsetiske Komité i Denmark |
healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound |
Vasodilator Agents Central Nervous System Diseases Pain Headache Disorders, Primary Healthy Cardiovascular Agents Brain Diseases |
Neuroprotective Agents Headache Disorders Signs and Symptoms Vasoactive Intestinal Peptide Migraine Disorders Headache Neurologic Manifestations |
Vasodilator Agents Physiological Effects of Drugs Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Pain Headache Disorders, Primary Cardiovascular Agents Brain Diseases Protective Agents |
Neuroprotective Agents Pharmacologic Actions Headache Disorders Signs and Symptoms Vasoactive Intestinal Peptide Migraine Disorders Therapeutic Uses Headache Neurologic Manifestations Central Nervous System Agents |