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

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide (VIP) in Migraineurs

Resource links provided by NLM:

MedlinePlus related topics: Headache

U.S. FDA Resources

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 (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

migraineurs

Exclusion Criteria:

cerebrovascular disorders, pregnancy, nursing

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: 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


ClinicalTrials.gov Identifier:	NCT00272896 History of Changes
Other Study ID Numbers:	KA04119
Study First Received:	January 4, 2006
Last Updated:	January 4, 2006

Keywords provided by Danish Headache Center:


Migraine VIP Transcranial Doppler Headache

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