Clinical Trials Directory

Trials / Completed

CompletedNCT01435941

Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine

Status
Completed
Phase
Study type
Observational
Enrollment
11,249 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGNon-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
DRUGTriptanParticipants 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

Timeline

Start date
2009-09-01
Primary completion
2011-02-01
Completion
2011-02-01
First posted
2011-09-19
Last updated
2017-05-16

Source: ClinicalTrials.gov record NCT01435941. Inclusion in this directory is not an endorsement.