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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Headache Migraine Vasoactive Intestinal Peptide Ultrasonography, Doppler, Transcranial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Vasoactive intestinal peptide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* migraineurs

Exclusion Criteria

* cerebrovascular disorders, pregnancy, nursing

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jes Olesen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center, Glostrup, Denmark

Locations

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Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA04119

Identifier Type: -

Identifier Source: org_study_id