An observational study in Migraine Disorders, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by GlaxoSmithKline · Observational
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 11,249 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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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).
Exclusion Criteria:
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
Drug: Non-steroidal anti-inflammatory drug (NSAID) · Drug: Triptan
Participants who self-report that they have treated headaches with any drug in the non-steroidal anti-inflammatory drug (NSAID) class
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
Also known as: Amerge® is a registered trademark of GlaxoSmithKline, Zomig® is a registered trademark of AstraZeneca, Relpax® is a registered trademark of Pfizer, Inc., Maxalt® is a registered trademark of Merck & Co, Axert® is a registered trademark of Pharmacia, Frova® is a registered trademark of Elan Pharmaceuticals/UCB Pharma, Inc, Imitrex® is a registered trademark of GlaxoSmithKline
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
Time frame: survey administered annually for 5 years
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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