Migraine HeadacheNCT00460005
Clinical Study Of Migraine Evolution
An observational study of Migraine Headache, run by GlaxoSmithKline at 10 sites in Canada.
Trial summary
Understanding the speed at which migraine headaches develop is of importance to patients. Determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- How many people
- 250 participants
- Where
- 10 sitesCanada
- Study dates
- Jan 2006to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is outpatient.
- Subject has a diagnosis of migraine with/without aura according to IHS criteria, of at least 1 years duration.
- Subject is able to comprehend the study procedures and to comply with study requirements.
Who cannot join
- Subject has other chronic pain condition(s) not associated with migraine
- Subject is unable to understand the schedule/questionnaire.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
GSK Clinical Trials Call Centre
Calgary, Alberta, T2N 2T9
GSK Clinical Trials Call Centre
Halifax, Nova Scotia, B3H 3A7
GSK Clinical Trials Call Centre
Hamilton, Ontario, L8N 1Y2
GSK Clinical Trials Call Centre
Longueuil, Quebec, J4L 4N5
GSK Clinical Trials Call Centre
Montreal, Quebec, H3A 2B4
GSK Clinical Trials Call Centre
Richmond, British Columbia, V6X 1A3
GSK Clinical Trials Call Centre
Saint John, New Brunswick, E2L 4L2
GSK Clinical Trials Call Centre
Toronto, Ontario, M5S 1B6
GSK Clinical Trials Call Centre
Unionville, Ontario, L3R 0W7
GSK Clinical Trials Call Centre
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Multicenter Study to Determine the Clinical Characteristics of the Temporal Aspects of Migraine in a Canadian Population: Clinical Study Of Migraine Evolution (C-SOME)
Understanding the speed at which migraine headaches develop is of importance to patients. Determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. Patients who experience a slow pain build-up may gain more benefit from medications which have a slow onset of effect, high tolerability and long action. Conversely, medications with a rapid onset of effect may be of greater benefit to patients who experience rapid onset of migraine pain.
- Conditions
- Migraine Headache
- Keywords
- Migraine, headache, observational
- Medical subject headings
- Migraine Disorders, Headache
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, M.D., Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460005
- Sponsor's protocol ID
- S2W106188
- Status last verified
- Apr 2008
- First submitted
- 12 Apr 2007
- Last updated
- 15 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Determine the Clinical Characteristics of the Temporal Aspects of Migraine in a Canadian Population: Clinical Study Of Migraine Evolution (C-SOME)
- ClinicalTrials.gov ID
- NCT00460005
- Acronym / sponsor ID
- S2W106188
- Conditions
- Migraine Headache
- Keywords
- Migraine, headache, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 13 Apr 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.
Understanding the speed at which migraine headaches develop is of importance to patients. Determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. Patients who experience a slow pain build-up may gain more benefit from medications which have a slow onset of effect, high tolerability and long action. Conversely, medications with a rapid onset of effect may be of greater benefit to patients who experience rapid onset of migraine pain.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is outpatient.
- Subject has a diagnosis of migraine with/without aura according to IHS criteria, of at least 1 years duration.
- Subject is able to comprehend the study procedures and to comply with study requirements.
Key exclusion criteria (2 listed)
- Subject has other chronic pain condition(s) not associated with migraine
- Subject is unable to understand the schedule/questionnaire.
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 15 Apr 2008.
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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.
GSK Clinical Trials, M.D. study director
GlaxoSmithKline
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Headache, run by GlaxoSmithKline at 10 sites in Canada.
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 3 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: finished, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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 15 Apr 2008.