NCT00291395

Brief Summary

Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if PGI2 is involved in headache pathophysiology.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
Last Updated

October 26, 2006

Status Verified

September 1, 2005

First QC Date

February 13, 2006

Last Update Submit

October 25, 2006

Conditions

HeadacheMigraine

Outcome Measures

Primary Outcomes (1)

  • Headache

Secondary Outcomes (1)

  • rCBF, blood flow, diameter of STA/RA, HR, BP

Interventions

PGI2DRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers,

You may not qualify if:

  • Primary headache,
  • headache on the day of investigation,
  • Hypertension,
  • hypotension,
  • pregnant/nursing
  • Daily intake of medication (except oral contraceptives)
  • Cardiovascular or CNS disease
  • Drug/Alcohol abuse
  • Psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Glostrup, DK-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

  • Troels Wienecke, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

September 1, 2005

Last Updated

October 26, 2006

Record last verified: 2005-09

Locations

DK(1)