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

NCT ID: NCT01435941

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11249 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-02-28

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.

Conditions

Migraine Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Non-steroidal anti-inflammatory drug (NSAID)

Intervention Type: DRUG

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

Triptan

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention 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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112630

Identifier Type: -

Identifier Source: org_study_id