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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01435941
Enrollment
11249
Registered
2011-09-19
Start date
2009-09-30
Completion date
2011-02-28
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Keywords

mailed survey, non-steroidal anti-inflammatory drug, migraine disorders, headache

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.

Interventions

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

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who progress from EM to CMsurvey administered annually for 5 yearsThe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026