Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
NCT ID: NCT06972056
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1335 participants
INTERVENTIONAL
2025-07-09
2029-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atogepant
Participants who are randomized to this arm will take up to 60mg daily for 12 weeks.
Atogepant 60 mg
Atogepant at a dose up to 60 mg daily.
Propranolol
Participants randomized to this arm will take up to 160 mg daily for 12 weeks.
Propranolol 160 mg
Daily propranolol up to 80 mg twice daily.
Topiramate
Participants randomized to this arm will take up to 100 mg daily for 12 weeks .
Topiramate 100 mg
Daily topiramate, up to 50 mg twice daily
Interventions
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Atogepant 60 mg
Atogepant at a dose up to 60 mg daily.
Propranolol 160 mg
Daily propranolol up to 80 mg twice daily.
Topiramate 100 mg
Daily topiramate, up to 50 mg twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 headache of moderate to severe intensity that lasts for at least four hours, or a day on which a migraine-specific acute medication is taken to treat headache.
* If already taking a migraine preventive treatment, willing to continue with that treatment without dose change during the first 16 weeks of the study, including the 4-week run-in phase and 12-week randomized phase.
* Not pregnant or breastfeeding
* Women of childbearing potential must agree to use effective methods of contraception to reduce the risk of pregnancy.
* Willingness and ability to provide informed consent.
* Willingness and ability to complete all research visits.
Exclusion Criteria
* Currently taking atogepant, propranolol, or topiramate\*
* Previously took atogepant, propranolol, or topiramate\*
* Unwillingness to take atogepant, topiramate, or propranolol.
* Current use of a CGRP-targeting preventive medication or beta-blocker
* Migraine with brainstem aura
* Hemiplegic migraine
* Retinal migraine
* Migraine aura without headache (exclusively)
* Pure menstrual migraine
* Trigeminal autonomic cephalalgias
* Facial neuralgias
* Secondary headache disorders (medication overuse headache is not an exclusion)
* Migraine preventive treatment has been started or dose has been changed within 12 weeks prior to potential enrollment.
* Used opioids or butalbital on five or more days per month on average for at least 3 months prior to enrollment.
* Current or past epilepsy
* Severe hepatic impairment
* Moderate or more severe renal impairment \* Occasional as needed use of propranolol, currently or in the past, is not an exclusion, such as taking as needed propranolol for treatment of anxiety.
18 Years
70 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Patient-Centered Outcomes Research Institute
OTHER
AbbVie
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Todd J. Schwedt
Principal Investigator
Principal Investigators
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Todd J Schwedt, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Northern Arizona Healthcare
Flagstaff, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
USC Keck
Los Angeles, California, United States
Clinical Research Institute
Los Angeles, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Apple Med Research
Miami, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University St Louis
St Louis, Missouri, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MI-2023C2-33021
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-012753
Identifier Type: -
Identifier Source: org_study_id
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