NCT00510172

Brief Summary

We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial vasodilatation in migraineurs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 1, 2007

Status Verified

July 1, 2007

First QC Date

July 30, 2007

Last Update Submit

July 30, 2007

Conditions

HeadacheMigraineVasodilatation

Keywords

HeadacheMigraineVasodilatation

Outcome Measures

Primary Outcomes (1)

  • Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery.

    14 hours

Secondary Outcomes (1)

  • Blood pressure, pulse

    100 min

Study Arms (2)

1

ACTIVE COMPARATOR

Active treatment

Drug: Prostacyclin, PGI2

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Prostacyclin, PGI2DRUG

10 ng/kg/min of epoprostenol (stable PGI2)

1
PlaceboDRUG

NaCL 0,9%

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • migraine without aura and healthy apart from that
  • age 18-55 years
  • Secure contraceptives

You may not qualify if:

  • Tension Type Headache more than 3 time a month
  • Other primary headaches
  • Medication prior to the study (closer than 4 times plasma halflife)
  • Migraine or headache 5 days prior to study.
  • Hypertension (systolic BP \>150 mmHg and/or diastolic BP \>100 mmHg).
  • Hypotension (systolic BP \<90 mmHg and/or diastolic BP \<50 mmHg).
  • Heart-vessel disease of any kind incl cerebrovascular disease.
  • Anamnestic or clinical signs of psychiatric disease or abuse.
  • Anamnestic or clinical signs of disease of any kind relevant for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Copenhagen, Glostrup, DK-2600, Denmark

RECRUITING

MeSH Terms

Conditions

HeadacheMigraine DisordersAneurysm

Interventions

Epoprostenol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins IProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Troels Wienecke, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Troels Wienecke, MD

CONTACT

+ 45 43 23 45 14trowie01@glo.regionh.dk

Study Design

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

Study Record Dates

First Submitted

July 30, 2007

First Posted

August 1, 2007

Study Start

December 1, 2006

Study Completion

September 1, 2007

Last Updated

August 1, 2007

Record last verified: 2007-07

Locations

DK(1)