Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Disorders
Intervention: Non-steroidal anti-inflammatory drug (NSAID) (Drug); Triptan (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Number of participants who progress from EM to CM
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Responses to questions suggest that the respondent's diagnosis is not migraine or CM
Locations and Contacts
Additional Information
Starting date: September 2009
Last updated: September 21, 2011
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