Last updated: 11/07/2018 04:55:31

Non-steroidal anti-inflammatory drugs alone or with a triptan and reports of transition from episodic to chronic migraine

GSK study ID
112630
See study documents
Clinicaltrials.gov ID
NCT01435941
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Non-steroidal anti-inflammatory drugs alone or with a triptan and reports of transition from episodic to chronic migraine
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants who progress from EM to CM

Timeframe: survey administered annually for 5 years

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Non-steroidal anti-inflammatory drug (NSAID)
  • Drug: Triptan
    • Enrollment:
    11249
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Lipton RB, Serrano D, Nicholson RA, Buse DC, Runken MC, Reed M.Impact of NSAID and Triptan Use on Developing Chronic Migraine: Results From the American Migraine Prevalence and Prevention (AMPP) Study.Headache.2013;53(10):1548-1563
    Stewart WF, Wood GC, Bruce C, Buse DC, Runken MC, Lipton RB. Longitudinal Change in Migraine Headache-Days and Indirect Cost Consequences. Journal of Occupational and Environmental Medicine. 2011;53(5):478-487.
    Medical condition
    Migraine Disorders
    Product
    naproxen
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to February 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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)
    • Responses to questions suggest that the respondent's diagnosis is not migraine or CM
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-14-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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