NCT00272896

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

January 9, 2006

Status Verified

October 1, 2004

First QC Date

January 4, 2006

Last Update Submit

January 4, 2006

Conditions

HeadacheMigraineVasoactive Intestinal PeptideUltrasonography, Doppler, Transcranial

Keywords

MigraineVIPTranscranial DopplerHeadache

Outcome Measures

Primary Outcomes (2)

  • Headache

  • Intra- and extracranial vasodilation

Secondary Outcomes (2)

  • arterial blood pressure

  • heart rate

Interventions

Vasoactive intestinal peptideDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • migraineurs

You may not qualify if:

  • cerebrovascular disorders, pregnancy, nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

HeadacheMigraine Disorders

Interventions

Vasoactive Intestinal Peptide

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Jes Olesen, MD, PhD

    Danish Headache Center, Glostrup, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

October 1, 2004

Study Completion

September 1, 2005

Last Updated

January 9, 2006

Record last verified: 2004-10

Locations

DK(1)