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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


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.