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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435941
First received: September 8, 2011
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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 Intervention
Migraine Disorders
Drug: Non-steroidal anti-inflammatory drug (NSAID)
Drug: Triptan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of participants who progress from EM to CM [ Time Frame: survey administered annually for 5 years ] [ Designated as safety issue: No ]
    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


Enrollment: 11249
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The American Migraine Prevalence and Prevention (AMPP) study is a multi-year longitudinal population-based study that follows a cohort of headache sufferers with severe headaches. From 2004 to 2009, respondents with headaches completed mailed questionnaires. Respondents had been screened from 120,000 US households and 24,000 individuals with severe headaches were invited to respond to annual questionnaires. Within the 2005 EM cohort a transition was defined to have occurred if in the observed year a respondent was CM and in the year immediately preceding that year a subject was EM. Participants were followed for up to 4 years with the provision that the individual provided data in 2005 and then in at least one subsequent year (2006-2009).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435941

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01435941     History of Changes
Other Study ID Numbers: 112630
Study First Received: September 8, 2011
Last Updated: September 21, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
mailed survey
non-steroidal anti-inflammatory drug
migraine disorders
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 23, 2014