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Completed

NCT Number: NCT01435941

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-steroidal anti-inflammatory drug (NSAID)

Drug

Participants who self-report that they have treated headaches with any drug in the non-steroidal anti-inflammatory drug (NSAID) class

Triptan

Drug

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

Other names: 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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 19, 2011
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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