Migraine DisordersNCT01435941
Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
An observational study of Migraine Disorders, run by GlaxoSmithKline.
Trial summary
Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Non-steroidal anti-inflammatory drug (NSAID) and Triptan
- How many people
- 11,249 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Feb 2011
- 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
Study population: The American Migraine Prevalence and Prevention (AMPP) study is a multi-year longitudinal population-based study that follows a cohort of headache sufferers with severe headaches. From 2004 to 2009, respondents with headaches completed mailed questionnaires. Respondents had been screened from 120,000 US households and 24,000 individuals with severe headaches were invited to respond to annual questionnaires. Within the 2005 EM cohort a transition was defined to have occurred if in the observed year a respondent was CM and in the year immediately preceding that year a subject was EM. Participants were followed for up to 4 years with the provision that the individual provided data in 2005 and then in at least one subsequent year (2006-2009).
Who may be able to join
- Respondents age 18 or older at the time of survey completion
- Respondents completed the questionnaires in 2004 and at least one other year (2005, 2006, 2007, 2008, 2009)
- Based on the respondents answers to the 2004 survey, their symptoms meet the criteria for EM which is characterized by headaches meeting International Classification of Headache Disorders - 2 (ICHD-2) criteria for migraine 1-14 days a month
Who cannot join
- Responses to questions suggest that the respondent's diagnosis is not migraine or CM
About this study
Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that increase or decrease the risk of developing CM. One factor that appears especially relevant is symptomatic medication use. The current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has on the likelihood of developing CM.
This study is a retrospective observational cohort study of data collected via mail survey and collated in the American Migraine Prevalence and Prevention (AMPP) database.
Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States (US) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. This analysis uses data from respondents who meet second edition of the International Headache Classification-2 (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.
- Conditions
- Migraine Disorders
- Being tested
- Non-steroidal anti-inflammatory drug (NSAID), Triptan
- Keywords
- mailed survey, non-steroidal anti-inflammatory drug, migraine disorders, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-steroidal anti-inflammatory drug (NSAID)Drug
Participants who self-report that they have treated headaches with any drug in the non-steroidal anti-inflammatory drug (NSAID) class
TriptanDrug
Also called Amerge® is a registered trademark of GlaxoSmithKline, Zomig® is a registered trademark of AstraZeneca, Relpax® is a registered trademark of Pfizer, Inc.
Participants who self-report that they have treated headaches with any drug in the NSAID class and any drug in the triptan class including naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, and zolmitriptan
| Study group | Role | What they receive |
|---|---|---|
| Respondents who report episodic migraines (EM) | Survey respondents whose headaches meet the diagnostic criteria for migraine and report that they experienced between 1 and 14 headache days in the month prior to the survey administration Receives: Drug: Non-steroidal anti-inflammatory drug (NSAID); Drug: Triptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who progress from EM to CM
The number of participants with episodic migraine (EM), characterized by headaches on 1 to 14 days per month, who report symptoms of chronic migraine (CM), 15 or more headaches per month, in one of the years of follow up
Measured: survey administered annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435941
- Sponsor's protocol ID
- 112630
- Status last verified
- May 2017
- First submitted
- 8 Sep 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
- ClinicalTrials.gov ID
- NCT01435941
- Acronym / sponsor ID
- 112630
- Conditions
- Migraine Disorders
- Keywords
- mailed survey, non-steroidal anti-inflammatory drug, migraine disorders, headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,249 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Sep 2011 (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.
Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that increase or decrease the risk of developing CM. One factor that appears especially relevant is symptomatic medication use. The current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has on the likelihood of developing CM.
This study is a retrospective observational cohort study of data collected via mail survey and collated in the American Migraine Prevalence and Prevention (AMPP) database.
Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States (US) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. This analysis uses data from respondents who meet second edition of the International Headache Classification-2 (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respondents who report episodic migraines (EM) | – | Drug: Non-steroidal anti-inflammatory drug (NSAID), Drug: TriptanSurvey respondents whose headaches meet the diagnostic criteria for migraine and report that they experienced between 1 and 14 headache days in the month prior to the survey administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The American Migraine Prevalence and Prevention (AMPP) study is a multi-year longitudinal population-based study that follows a cohort of headache sufferers with severe headaches. From 2004 to 2009, respondents with headaches completed mailed questionnaires. Respondents had been screened from 120,000 US households and 24,000 individuals with severe headaches were invited to respond to annual questionnaires. Within the 2005 EM cohort a transition was defined to have occurred if in the observed year a respondent was CM and in the year immediately preceding that year a subject was EM. Participants were followed for up to 4 years with the provision that the individual provided data in 2005 and then in at least one subsequent year (2006-2009).
Key inclusion criteria (3 listed)
- Respondents age 18 or older at the time of survey completion
- Respondents completed the questionnaires in 2004 and at least one other year (2005, 2006, 2007, 2008, 2009)
- Based on the respondents answers to the 2004 survey, their symptoms meet the criteria for EM which is characterized by headaches meeting International Classification of Headache Disorders - 2 (ICHD-2) criteria for migraine 1-14 days a month
Key exclusion criteria (1 listed)
- Responses to questions suggest that the respondent's diagnosis is not migraine or CM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-steroidal anti-inflammatory drug (NSAID)Participants who self-report that they have treated headaches with any drug in the non-steroidal anti-inflammatory drug (NSAID) class | Drug | Respondents who report episodic migraines (EM) |
| TriptanAlso: Amerge® is a registered trademark of GlaxoSmithKline, Zomig® is a registered trademark of AstraZeneca, Relpax® is a registered trademark of Pfizer, Inc.Participants who self-report that they have treated headaches with any drug in the NSAID class and any drug in the triptan class including naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, and zolmitriptan | Drug | Respondents who report episodic migraines (EM) |
Primary outcome
Number of participants who progress from EM to CM
Time frame: survey administered annually for 5 years
The number of participants with episodic migraine (EM), characterized by headaches on 1 to 14 days per month, who report symptoms of chronic migraine (CM), 15 or more headaches per month, in one of the years of follow up
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 16 May 2017.
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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 study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by GlaxoSmithKline.
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 1 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 16 May 2017. 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?
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.
What does the primary outcome measure?
Number of participants who progress from EM to CM (time frame: survey administered annually for 5 years). It is what the study was designed to measure, not a finding.
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 16 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.