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Inflammatory Markers Identification in Migraine Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01618201
Recruitment Status : Unknown
Verified September 2009 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

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.

Condition or disease
Inflammation Migraine Headache

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Inflammatory Markers Identification in Migraine Patients
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

50 subjects with migraine without aura
Inflammation Migraine Headache
50 subjects with migraine with aura
Inflammation Migraine Headache
50 subjects with tension headache and cluster headache
Inflammation Migraine Headache
50 healthy subjects
Inflammation Migraine Headache

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The patient group will consist of 150 subjects with various headache types treated at the headache clinic at the Sourasky Medical Center, Tel-Aviv, ISRAEL, and 50 healthy controls.

Inclusion Criteria:

  1. Men or women older than 18 years of age.
  2. Diagnosed with migraine, tension type headache or cluster headache according to International Headache Society criteria (24).
  3. Headache duration is at least 1 year prior to study entry.
  4. The frequency of migraine or tension type headache is 1-6 attacks in one month. Cluster headache duration is 2-4 weeks every year.
  5. No prior history of cerebral or cardiac vascular event

Exclusion Criteria:

  1. Pregnant or breast feeding women.
  2. Subjects with permanent treatment with steroids
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Responsible Party: Michal Roll PhD,MBA, Division Rnd Director, Tel-Aviv Sourasky Medical Center Identifier: NCT01618201    
Other Study ID Numbers: TASMC-11-AM-521-CTIL
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: September 2009
Keywords provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:
Additional relevant MeSH terms:
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Migraine Disorders
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations