NCT00255320

Brief Summary

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.

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 Dec 2003

Shorter than P25 for not_applicable

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

December 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2005

Completed
Last Updated

December 9, 2005

Status Verified

December 1, 2003

First QC Date

November 16, 2005

Last Update Submit

December 7, 2005

Conditions

Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound

Keywords

healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Interventions

VIPDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- healthy volunteers

You may not qualify if:

  • \- migraine cerebrovascular disorders pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center , KAS Glostrup

Glostrup, Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

HeadacheMigraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jakob Møller Hansen, MD

    Danish Headache Center

    STUDY CHAIR

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

November 16, 2005

First Posted

November 18, 2005

Study Start

December 1, 2003

Study Completion

June 1, 2004

Last Updated

December 9, 2005

Record last verified: 2003-12

Locations

DK(1)