Identification of Inflammatory Markers in Migraine Patients
1 other identifier
observational
250
1 country
1
Brief Summary
Migraine is prevalent in 10-12% of the population. It involves the development of a cranial perivascular neurogenic inflammation. Recent information suggests that migraine might be a risk factor to stroke. The possible mechanisms that might relate migraine and stroke are: 1. Migraineous infarction 2. A primary endothelial disorder. 3. Genetic relation 4. An ongoing inflammatory process. C reactive protein (CRP) is a sensitive marker for an inflammatory process.The data on the relation of migraine to inflammation is limited. The aim of the current study is to assess inflammatory factors as possible markers for migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 2, 2009
September 1, 2009
1.7 years
September 1, 2009
September 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate if the levels of inflammatory markers in patients with migraine is higher compared to the levels of these markers in the control groups.
1.5 years
Secondary Outcomes (1)
To evaluate the levels of inflammatory markers in-between migraine and other forms of headaches.
1.5 years
Study Arms (5)
migraine1
50 subjects with migraine without aura
migraine 2
50 subjects with migraine with aura
tension
50 subjects with tension headache
cluster
50 subjects with cluster headache
Healthy
50 healthy subjects
Eligibility Criteria
The patient group will consist of 200 subjects with various headache types treated at the headache clinic at the Sourasky Medical Center, Tel-Aviv, ISRAEL, and 50 healthy controls.
You may qualify if:
- Men or women older than 18 years of age.
- Diagnosed with migraine, tension type headache or cluster headache according to International Headache Society criteria (24).
- Headache duration is at least 1 year prior to study entry.
- The frequency of migraine or tension type headache is 1-6 attacks in one month. Cluster headache duration is 2-4 weeks every year.
- No prior history of cerebral or cardiac vascular event.
You may not qualify if:
- Pregnant or breast feeding women.
- Subjects with permanent treatment with steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The headache clinic, Sourasky Medical Center Tel Aviv
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amnon mosek
The Headache and Facial pain Clinic, the departement of Neurology, Sourasky Medical Center, Tel Aviv
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 2, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
September 2, 2009
Record last verified: 2009-09