NCT00969995

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 2, 2009

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

September 1, 2009

Last Update Submit

September 1, 2009

Conditions

Keywords

inflammationmigraineheadache

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

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

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

Location

MeSH Terms

Conditions

InflammationMigraine DisordersHeadache

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Amnon mosek

    The Headache and Facial pain Clinic, the departement of Neurology, Sourasky Medical Center, Tel Aviv

    PRINCIPAL INVESTIGATOR

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

Locations