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

NCT01435941 | Completed

• 1 other identifier: 112630
• Study Type: observational
• Target: 11,249
• Locations: 0 countries
• Sites: N/A

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

Keywords

mailed survey; non-steroidal anti-inflammatory drug; migraine disorders; headache

Outcome Measures

Primary Outcomes (1)

• Number of participants who progress from EM to CM

  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

  survey administered annually for 5 years

Study Arms (1)

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); Drug: Triptan

Interventions

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

Respondents who report episodic migraines (EM)

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

Also known as: 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

Respondents who report episodic migraines (EM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Responses to questions suggest that the respondent's diagnosis is not migraine or CM

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Tryptamines

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 16, 2017

Record last verified: 2017-05