Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs - Full Text View

Sponsored by:	Danish Headache Center
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00272896

Purpose

We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters.

Condition	Intervention
Headache Migraine Vasoactive Intestinal Peptide Ultrasonography, Doppler, Transcranial	Drug: Vasoactive intestinal peptide

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Vasoactive intestinal peptide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide (VIP) in Migraineurs

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:

Headache
Intra- and extracranial vasodilation

Secondary Outcome Measures:

arterial blood pressure
heart rate

Estimated Enrollment:	12
Study Start Date:	October 2004
Estimated Study Completion Date:	September 2005

Detailed Description:

We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters. The subjects were randomly allocated to the infusion of 8pmol/kg/min VIP or placebo (isotonic saline), duration 25min. Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmMCA), superficial temporal artery diameter, end-expiratory CO2 and vital signs were recorded at baseline and then every 10 min until 120 min after start of the infusion. The patients received a headache diary for the following 12 hours after infusion.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

migraineurs

Exclusion Criteria:

cerebrovascular disorders, pregnancy, nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272896

Locations

Denmark
Glostrup Hospital
Glostrup, Denmark, 2600

Sponsors and Collaborators

Danish Headache Center

Investigators

Principal Investigator:

Jes Olesen, MD, PhD

Danish Headache Center, Glostrup, Denmark

More Information

Homepage of the Danish Headache Center This link exits the ClinicalTrials.gov site

Study ID Numbers:	KA04119
Study First Received:	January 4, 2006
Last Updated:	January 4, 2006
ClinicalTrials.gov Identifier:	NCT00272896
Health Authority:	Denmark: Ethics Committee

Keywords provided by Danish Headache Center:

Migraine
VIP
Transcranial Doppler
Headache

Study placed in the following topic categories:

Signs and Symptoms
Vasoactive Intestinal Peptide
Migraine Disorders
Headache
Central Nervous System Diseases

Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Gastrointestinal Agents

Cardiovascular Agents
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009