Comparing Migraine Prevention Medications: The APT Study

This study is comparing three medications used to prevent migraines: atogepant, propranolol, and topiramate. Researchers want to see if one of these medications works better or is easier to tolerate than the others for people with migraine. You might be able to join if you are an adult between 18 and 70 years old, have had migraines for at least a year, and experience at least four moderate to severe migraines per month. The study will measure success by seeing how many participants have a 50% or greater reduction in their moderate to severe headache days after 9-12 weeks on the assigned medication. The current recruitment status is unclear.

Study design
This is a randomized study comparing three different medications for migraine prevention, with a planned enrollment of 1335 participants.
What's involved
You would keep a daily headache diary for four weeks, and then for the first 16 weeks after randomization. You would also have research visits at baseline, four weeks later, and then at weeks 4, 8, 12, 24, and 48 after starting the study medication.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 48 weeks after randomization, with the primary outcome measured at weeks 9-12 post-randomization.

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NCT06972056

Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Recruiting
PHASE4Ages 18–70InterventionalTreatment
Mayo Clinic
~1,335 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Atogepant 60 mgPropranolol 160 mgTopiramate 100 mg

At a glance

Recruiting sites
36 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
Measured over Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization
Migraine
36 sites across 22 states
North Carolina5
California4
Florida4
New York3
Arizona2
Wisconsin2
Colorado1
Kansas1
  • Todd J Schwedt, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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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.
  • Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization

    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.