NCT01618201

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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 13, 2012

Status Verified

September 1, 2009

Enrollment Period

2 years

First QC Date

June 10, 2012

Last Update Submit

June 12, 2012

Conditions

InflammationMigraineHeadache

Keywords

InflammationMigraineHeadache

Study Arms (4)

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

Eligibility Criteria

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

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

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Rnd Director

Study Record Dates

First Submitted

June 10, 2012

First Posted

June 13, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 13, 2012

Record last verified: 2009-09