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TRIUMPH


Title preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems
Therapeutic Area Migraine
Principal Investigator David Thaler, MD
Min Age 18 Years
Gender Any
Contact
617-636-7606
neuroresearch@tuftsmedicalcenter.org

Overview

The purpose of this study is to collect information about treatment patterns, effects, and outcomes in patients with migraines who are switching or initiating a pharmacologic treatment for migraine prevention. This is an observational study which means there will be no treatment added or taken away.

Study Details

Inclusion Criteria

  • A diagnosis of migraine, with or without aura, or chronic migraine, as determined by the study investigator (per International Headache Society International Classification of Headache Disorders 3rd edition guidelines)
  • Switching or initiating a new pharmacologic migraine preventive treatment
  • Note that:
  • The initiating treatment cannot be one that has been taken in the prior 12 months.
  • Concurrent migraine preventive treatment, including pharmacological, nonpharmacological, and any over-the-counter supplement taken specifically for migraine prevention, is allowed, provided the existing treatment(s) has (have) been at a stable dose for at least 3 months prior to entry. For nonpharmacological treatment, the regimen must have been stable for at least 3 months prior to entry
  • Able to reliably report on historical details regarding frequency of monthly migraine headache days during the past month

Exclusion Criteria

  • Are investigator site personnel directly affiliated with the study and/or their immediate families.
  • Are terminally ill.
  • Are participating in another study that includes treatment with an investigational drug and/or intervention at the same time as enrollment in the current study

Study Requirements

Your participation in the study will be either a single-day assessment or it will last 2 years. This depends on which preventive migraine medication you are prescribed as part of your routine care.

You will be asked to complete short questionnaires lasting 1-5 minutes each. If you qualify for the stage of the study that lasts 2 years, you will be asked to keep an electronic subject headache diary that you will be encouraged to fill out every time you experience a headache. You will fill out additional questionnaires due every 3 months or less often.