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Inflammation | Identification of Inflammatory Markers in Migraine Patients

Inflammation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Inflammation

Migraine

Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

migraine150 subjects with migraine without aura

migraine 250 subjects with migraine with aura

tension50 subjects with tension headache

cluster50 subjects with cluster headache

Healthy50 healthy subjects

Study Status

Unknown status

Start Date: September 2009

Completed Date: December 2011

Phase: N/A

Type: Observational

Design:

Primary Outcome: 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.

Secondary Outcome: To evaluate the levels of inflammatory markers in-between migraine and other forms of headaches.

Study sponsors, principal investigator, and references

Principal Investigator: Amnon mosek

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00969995

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