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Identification of Inflammatory Markers in Migraine Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00969995
First received: September 1, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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
Inflammation
Migraine
Headache

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Identification of Inflammatory Markers in Migraine Patients

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the levels of inflammatory markers in-between migraine and other forms of headaches. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969995

Contacts
Contact: Zipi Hybloom 972-3-6974874 zipihy@tasmc.health.gov.il
Contact: Amnon Mosek, MD 972-3-6974874 mosek@tasmc.health.gov.il

Locations
Israel
The headache clinic, Sourasky Medical Center Tel Aviv Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Zipi Hybloom     972-3-6974874     zipihy@tasmc.health.gov.il    
Contact: Amnon Mosek, MD     972-3-6974874     mosek@tasmc.health.gov.il    
Sub-Investigator: Shlomo Berliner, MD            
Sub-Investigator: Marina Dano, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Amnon mosek The Headache and Facial pain Clinic, the departement of Neurology, Sourasky Medical Center, Tel Aviv
  More Information

No publications provided

Responsible Party: Dr. Amnon Mosek, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00969995     History of Changes
Other Study ID Numbers: TASMC-08-AM-197-CTIL
Study First Received: September 1, 2009
Last Updated: September 1, 2009
Health Authority: ISRAEL: Tasmc-Monitoring Committee

Keywords provided by Tel-Aviv Sourasky Medical Center:
inflammation
migraine
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Inflammation
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013