InflammationNCT01618201
Inflammatory Markers Identification in Migraine Patients
An observational study of Inflammation and Migraine, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Migraine, Headache
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant or breast feeding women.
- Subjects with permanent treatment with steroids
About 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.
Read the detailed description
Migraine is prevalent in 10-12% of the population, with female preponderance (1). Migraine may cause a significant distress and reduction of the quality of life of the patients, of whom in almost a third of them the migraine attack reduces the ability to function. The main form of migraine is migraine without aura while 20-30% of the patients have migraine with aura (2) which is a focal neurological phenomenon that occurs 20-30 minutes prior to the migraine pain. The development of a cranial perivascular neurogenic inflammation hallmarks the migraine attack which involves the secretion of vasodilatatory and inflammatory peptides from the perivascular intracranial trigeminal terminals (3).
Recent information suggests that migraine might be a risk factor to stroke. Migraineurs were found to carry a higher risk to develop stroke when compared to subject without migraine, and this risk was higher among patients with migraine with aura (4-6) and in particular in women 45 years of age or younger (7-8). Brain MRI studies showed that migraineurs have more sub-clinical infarcts and abnormal white matter signals, in particular among young women with migraine with aura compared to normal controls (9-10). Furthermore, the findings in a large prospective study suggest that the possible relation between migraine and vascular disorders is even larger, showing that patients with migraine with aura carry a higher risk to develop stroke but also myocardial infarction, compared to those who do not suffer from migraine (11). The mechanisms that relate migraine to stroke are unknown. The possible mechanisms that might relate migraine and stroke are:
- The pathophysiological vascular changes that occur during migraine are the direct (migraineous infarction) or indirect cause of stroke (12).
- Migraineurs have a primary endothelial disorder which could be expressed in several vascular aspects such as migraine, stroke, Renauld's phenomenon and PFO.
- Migraine and stroke are genetically related as in familial hemiplegic migraine.
- Migraine is accompanied by, or the cause of, an ongoing inflammatory process which is the cause of stroke (13).
C reactive protein (CRP) is a sensitive marker for an inflammatory process, rising quickly in response to an inflammation or tissue damage. CRP in not only a marker but also involved in the identification of pathogens, activation of the complementary system and phagocytic response and, therefore, has an important role in the protection from infections (14). It also has a role in the restoration of the structure and activity of damaged tissues (15). On the other hand, high levels of CRP were related to higher risk to develop a cardiovascular disease or stroke (16, 17). CRP might be a primary risk factor for these disorders (18, 19) possibly through inflammatory or hypercoagulability mechanisms (20, 21). Nevertheless, no significant correlation was found between CRP and atherosclerosis.
The data on the relation of migraine to inflammation is limited. In a retrospective study, with no control group, data on patients considered with a complicated medical problem by a neurologist were collected from the patients' files. Out of 60 patients with migraine (50% migraine with aura) 43% had high CRP levels (>3mg%; in 55% of those with migraine without aura and in 32% of those with migraine with aura) (22). A prospective study of 50 migraineurs (64% with aura) found a significantly higher CRP levels in the migraine group compared to the controls and, as the previous study, those with migraine without aura had higher levels of CRP (23). These findings possibly point on a relation between migraine and inflammation.
Aim of the study To examine values of a 'baseline inflammatory profile' in patients with migraine with and without aura in comparison to control groups in order to identify an inflammatory marker.
- Main study objective: 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 study objective: to evaluate the levels of inflammatory markers in-between migraine and other forms of headaches.
- Conditions
- Inflammation, Migraine, Headache
- Keywords
- Inflammation, Migraine, Headache
- Medical subject headings
- Inflammation, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618201
- Sponsor's protocol ID
- TASMC-11-AM-521-CTIL
- Status last verified
- Sep 2009
- First submitted
- 10 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers Identification in Migraine Patients
- ClinicalTrials.gov ID
- NCT01618201
- Acronym / sponsor ID
- TASMC-11-AM-521-CTIL
- Conditions
- Inflammation, Migraine, Headache
- Keywords
- Inflammation, Migraine, Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Migraine is prevalent in 10-12% of the population, with female preponderance (1). Migraine may cause a significant distress and reduction of the quality of life of the patients, of whom in almost a third of them the migraine attack reduces the ability to function. The main form of migraine is migraine without aura while 20-30% of the patients have migraine with aura (2) which is a focal neurological phenomenon that occurs 20-30 minutes prior to the migraine pain. The development of a cranial perivascular neurogenic inflammation hallmarks the migraine attack which involves the secretion of vasodilatatory and inflammatory peptides from the perivascular intracranial trigeminal terminals (3).
Recent information suggests that migraine might be a risk factor to stroke. Migraineurs were found to carry a higher risk to develop stroke when compared to subject without migraine, and this risk was higher among patients with migraine with aura (4-6) and in particular in women 45 years of age or younger (7-8). Brain MRI studies showed that migraineurs have more sub-clinical infarcts and abnormal white matter signals, in particular among young women with migraine with aura compared to normal controls (9-10). Furthermore, the findings in a large prospective study suggest that the possible relation between migraine and vascular disorders is even larger, showing that patients with migraine with aura carry a higher risk to develop stroke but also myocardial infarction, compared to those who do not suffer from migraine (11). The mechanisms that relate migraine to stroke are unknown. The possible mechanisms that might relate migraine and stroke are:
- The pathophysiological vascular changes that occur during migraine are the direct (migraineous infarction) or indirect cause of stroke (12).
- Migraineurs have a primary endothelial disorder which could be expressed in several vascular aspects such as migraine, stroke, Renauld's phenomenon and PFO.
- Migraine and stroke are genetically related as in familial hemiplegic migraine.
- Migraine is accompanied by, or the cause of, an ongoing inflammatory process which is the cause of stroke (13).
C reactive protein (CRP) is a sensitive marker for an inflammatory process, rising quickly in response to an inflammation or tissue damage. CRP in not only a marker but also involved in the identification of pathogens, activation of the complementary system and phagocytic response and, therefore, has an important role in the protection from infections (14). It also has a role in the restoration of the structure and activity of damaged tissues (15). On the other hand, high levels of CRP were related to higher risk to develop a cardiovascular disease or stroke (16, 17). CRP might be a primary risk factor for these disorders (18, 19) possibly through inflammatory or hypercoagulability mechanisms (20, 21). Nevertheless, no significant correlation was found between CRP and atherosclerosis.
The data on the relation of migraine to inflammation is limited. In a retrospective study, with no control group, data on patients considered with a complicated medical problem by a neurologist were collected from the patients' files. Out of 60 patients with migraine (50% migraine with aura) 43% had high CRP levels (>3mg%; in 55% of those with migraine without aura and in 32% of those with migraine with aura) (22). A prospective study of 50 migraineurs (64% with aura) found a significantly higher CRP levels in the migraine group compared to the controls and, as the previous study, those with migraine without aura had higher levels of CRP (23). These findings possibly point on a relation between migraine and inflammation.
Aim of the study To examine values of a 'baseline inflammatory profile' in patients with migraine with and without aura in comparison to control groups in order to identify an inflammatory marker.
- Main study objective: 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 study objective: to evaluate the levels of inflammatory markers in-between migraine and other forms of headaches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breast feeding women.
- Subjects with permanent treatment with steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Migraine, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.