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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01435941
Collaborator
(none)
11,249
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Non-steroidal anti-inflammatory drug (NSAID)
  • Drug: Triptan

Study Design

Study Type:
Observational
Actual Enrollment :
11249 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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) class

Drug: 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
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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants who progress from EM to CM [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT01435941
    Other Study ID Numbers:
    • 112630
    First Posted:
    Sep 19, 2011
    Last Update Posted:
    May 16, 2017
    Last Verified:
    May 1, 2017

    Study Results

    No Results Posted as of May 16, 2017