Inflammatory Markers Identification 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 (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01618201
First received: June 10, 2012
Last updated: June 12, 2012
Last verified: September 2009
  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: Inflammatory Markers Identification in Migraine Patients

Resource links provided by NLM:


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

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  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 150 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, Division Rnd Director, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01618201     History of Changes
Other Study ID Numbers: TASMC-11-AM-521-CTIL
Study First Received: June 10, 2012
Last Updated: June 12, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Inflammation
Migraine
Headache

Additional relevant MeSH terms:
Headache
Inflammation
Migraine Disorders
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 July 22, 2014