NCT00374530

Brief Summary

Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.

Trial Health

80
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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

August 1, 2007

Status Verified

July 1, 2007

First QC Date

September 8, 2006

Last Update Submit

July 31, 2007

Conditions

HeadacheMigraine

Outcome Measures

Primary Outcomes (1)

  • Headache

Secondary Outcomes (1)

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

Interventions

PGE2DRUG

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 the 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

Interventions

Dinoprostone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Troels Wienecke, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

August 1, 2006

Last Updated

August 1, 2007

Record last verified: 2007-07

Locations

DK(1)