Status:
RECRUITING
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of Iowa
Patient-Centered Outcomes Research Institute
Conditions:
Migraine
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 me...
Detailed 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 info...
Eligibility Criteria
Inclusion
- 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 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
- Contraindications to taking atogepant, propranolol, or topiramate.
- 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.
Key Trial Info
Start Date :
July 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
1335 Patients enrolled
Trial Details
Trial ID
NCT06972056
Start Date
July 9 2025
End Date
December 1 2029
Last Update
November 17 2025
Active Locations (9)
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1
Northern Arizona Healthcare
Flagstaff, Arizona, United States, 86001
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
USC Keck
Los Angeles, California, United States, 90033
4
Clinical Research Institute
Los Angeles, California, United States, 90048