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
Troels Wienecke
MD,PhD
Danish Headache Center
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Prostaglandin F2alpha in a Human Headache ModelHeadacheNCT01327118Danish Headache Center12
Completed
Not Applicable
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2HeadacheMigraineNCT00374530Danish Headache Center12
Unknown
Not Applicable
Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2HeadacheVasodilatationMigraineNCT00510172Glostrup University Hospital, Copenhagen12
Terminated
Phase 1
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy VolunteersHeadacheMigraineNCT00291395Danish Headache Center12
Not yet recruiting
Not Applicable
Effects of Substance P on Headache Induction in Healthy IndividualsHealthy Volunteers OnlyNCT06632080Danish Headache Center21