Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
|ClinicalTrials.gov Identifier: NCT01435941|
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : May 16, 2017
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.
|Condition or disease||Intervention/treatment|
|Migraine Disorders||Drug: Non-steroidal anti-inflammatory drug (NSAID) Drug: Triptan|
|Study Type :||Observational|
|Actual Enrollment :||11249 participants|
|Official Title:||Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine|
|Study Start Date :||September 2009|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2011|
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
Drug: 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) classDrug: Triptan
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435941
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|