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.
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. Participants provide data using a headache diary (first 16 weeks of the study) and during research visits. The primary endpoint is the proportion of participants in each treatment group who are "treatment responders" defined as completing the first twelve weeks of the study on the assigned medication and having a 50% or greater reduction in moderate severe headache days during weeks 9-12 post-randomization compared to the four weeks pre-randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,335
Atogepant at a dose up to 60 mg daily.
Daily propranolol up to 80 mg twice daily.
Daily topiramate, up to 50 mg twice daily
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as: 1. Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND 2. Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
Time frame: Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization
Migraine Specific Quality-of-Life - Role Function-Restrictive
The role function-restrictive domain of the Migraine Specific Quality of Life questionnaire is a 7-item valid measure of functional impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness during the past four weeks.
Time frame: Week 12 post-randomization vs. baseline
Treatment Responder (propranolol vs. topiramate)
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as: 1. Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND 2. Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
Time frame: Weeks 9-12 post-randomization vs. the 4 weeks prior to randomization
Headache Impact Test-6 (HIT-6)
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RECRUITING...and 26 more locations
The HIT-6 is a six-item questionnaire that measures the impact headaches have on a person's ability to function on the job, at home, at school, and in social situations.
Time frame: week 12 post-randomization vs. baseline
Medication-Related Adverse Events
This medication-related adverse event outcome will consist of all adverse events that are deemed to be at least possibly related to the study medication.
Time frame: All 12 weeks of the randomized treatment phase