Experimental Headache Induced by Vasoactive Intestinal Polypeptide

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00255320
First received: November 16, 2005
Last updated: December 7, 2005
Last verified: December 2003
  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
Endpoint Classification: Pharmacodynamics Study
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

- migraine cerebrovascular disorders pregnancy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00255320     History of Changes
Other Study ID Numbers: VIP-KASGlo2004
Study First Received: November 16, 2005
Last Updated: December 7, 2005
Health Authority: Denmark: Den Centrale Videnskabsetiske Komité i Denmark

Keywords provided by Danish Headache Center:
healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound

Additional relevant MeSH terms:
Headache
Headache Disorders, Primary
Headache Disorders
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Vasoactive Intestinal Peptide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014