Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2011 | ||||
| Last Updated Date | September 21, 2011 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of participants who progress from EM to CM [ Time Frame: survey administered annually for 5 years ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01435941 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine | ||||
| Official Title ICMJE | Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine | ||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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). |
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| Condition ICMJE | Migraine Disorders | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | 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
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 11249 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01435941 | ||||
| Other Study ID Numbers ICMJE | 112630 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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