A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study
Mayo Clinic
Summary
This goal of this study is to compare three medications used for migraine preventive treatment. This study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others. Research participants will: * Be randomly assigned to one of the three medications. * Provide information about their migraine pattern using a daily headache diary and during research visits.
Description
This is a prospective, randomized, comparative effectiveness clinical trial of atogepant, propranolol, and topiramate for the prevention of migraine in adults. Eligible participants will provide information in a daily headache diary for four weeks. If after those four weeks they are still eligible for the study, they will be randomized to one of the study medications and receive study medication for twelve weeks. Research visits occur at baseline, four weeks later for the randomization visit, and then at post-randomization weeks four, eight, twelve, twenty-four, and forty-eight. Participant…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults, 18-70 years of age at the time of enrollment * Migraine with aura, migraine without aura, and/or chronic migraine; according to ICHD-3 diagnostic criteria. (Those with daily or continuous headaches are not excluded.) * Migraine onset prior to 50 years of age * Migraine present for at least 12 months at the time of enrollment * At least four "moderate to severe headache days" per month (by patient self-report and then confirmed during four-week pre-randomization headache diary phase) A "moderate to severe headache day" is defined as a day during which there is a h…
Interventions
- DrugAtogepant 60 mg
Atogepant at a dose up to 60 mg daily.
- DrugPropranolol 160 mg
Daily propranolol up to 80 mg twice daily.
- DrugTopiramate 100 mg
Daily topiramate, up to 50 mg twice daily
Locations (23)
- Northern Arizona HealthcareFlagstaff, Arizona
- Mayo Clinic ArizonaPhoenix, Arizona
- USC KeckLos Angeles, California
- Clinical Research InstituteLos Angeles, California
- Desert Physicians Medical GroupPalm Springs, California
- The Neurology GroupPomona, California