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Clinical Trials/NCT01384812
NCT01384812CompletedNot Applicable

Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.

Troels Wienecke1 site in 1 country12 target enrollmentStarted: September 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Headache score on a 10-point verbal rating scale (VRS).

Study Overview

Brief Summary

The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with migraine without aura

Exclusion Criteria

  • Tension type headache more than x 3 per month
  • Other forms for primary headache
  • Headache 24 h before the day of the investigation
  • Migraine 48 h before the day of the investigation
  • Hypertension
  • Hypotension
  • Pregnant/nursing
  • Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack)
  • Cardiovascular or central nervous system (CNS) disease
  • Drug/alcohol abuse
  • Psychiatric disease
  • Asthma or any other lung diseases

Arms & Interventions

Isoton sodium chloride

Placebo Comparator

Intervention: isoton sodium chloride (Drug)

Prostin E2 (dinoprostone)

Active Comparator

Intervention: dinoprostone (Drug)

Outcomes

Primary Outcomes

Headache score on a 10-point verbal rating scale (VRS).

Time Frame: 24 h

Incidence of headache 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache.

Secondary Outcomes

  • Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz).(90 min)
  • Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan.(90 min)
  • Mean arterial blood pressure (MAP).(90 min)
  • Electrocardiography (ECG).(90 min)
  • Heart rate (HR).(90 min)
  • End-tidal partial pressure of pCO2 (PetCO2).(90 min)
  • Transcutaneous arterial oxygen saturation (SAT)(90 min)

Investigators

Sponsor
Troels Wienecke
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Troels Wienecke

MD,PhD

Danish Headache Center

Study Sites (1)

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