MigraineNCT00471861
Inflammatory Markers in Patients With Active Migraine Headaches
An observational study of Migraine, run by Westside Family Medical Center, P.C. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2009
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Migraine
Who may be able to join
- Subjects must sign a written informed consent.
- Enrollment population would include males and females 21 years of age to 65 years of age.
- Non-migraine subjects will be allowed in the control group
- Have episodic migraine headaches
- Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed.
- Must be able to differentiate migraine headaches from other headaches
Who cannot join
- Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
- Basilar or hemiplegic migraine headaches.
- Pregnant woman or a nursing mother
- History (within 1 year) or current evidence of drug or alcohol abuse.
- More than 15 migraine headaches per month
- Chronic daily headaches
- Chronic use of NSAIDs
- Current participation in a research study or within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009
About this study
Official title: Does Migraine As A Partly Inflammatory Disease Increase The Inflammatory Markers Of The Patient When Actively Having a Migraine?
The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.
Read the detailed description
A random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be recruited mainly from the primary care practice. Recruitment will include males and females aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who do not have migraine headaches will also be enrolled and function as controls. Non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.
- Conditions
- Migraine
- Keywords
- Inflammatory Markers, Migraine
- Medical subject headings
- Migraine Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startMay 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westside Family Medical Center, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Gary E Ruoff, MD, Principal investigator, Westside Family Medical Center, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471861
- Sponsor's protocol ID
- 109944
- Status last verified
- Feb 2009
- First submitted
- 8 May 2007
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Migraine As A Partly Inflammatory Disease Increase The Inflammatory Markers Of The Patient When Actively Having a Migraine?
- ClinicalTrials.gov ID
- NCT00471861
- Acronym / sponsor ID
- 109944
- Conditions
- Migraine
- Keywords
- Inflammatory Markers, Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Westside Family Medical Center, P.C.University, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2007
- Study completion
- Feb 2009 (actual)
- First posted
- 10 May 2007 (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.
The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.
Detailed description
A random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be recruited mainly from the primary care practice. Recruitment will include males and females aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who do not have migraine headaches will also be enrolled and function as controls. Non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine
Key inclusion criteria (6 listed)
- Subjects must sign a written informed consent.
- Enrollment population would include males and females 21 years of age to 65 years of age.
- Non-migraine subjects will be allowed in the control group
- Have episodic migraine headaches
- Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed.
Key exclusion criteria (8 listed)
- Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
- Basilar or hemiplegic migraine headaches.
- Pregnant woman or a nursing mother
- History (within 1 year) or current evidence of drug or alcohol abuse.
- More than 15 migraine headaches per month
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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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.
Gary E Ruoff, MD principal investigator
Westside Family Medical Center, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Westside Family Medical Center, P.C. at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 8 Aug 2011.