Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Launched by MAYO CLINIC · May 7, 2025

Keywords

ClinConnect Summary

The APT Comparison Study is a clinical trial designed to compare the effectiveness of three medications used to prevent migraines: atogepant (a newer option), topiramate, and propranolol (two older treatments). The goal is to find out which medication works better and has fewer side effects. To participate in this study, you should be an adult between the ages of 18 and 70 who experiences frequent migraines. Specifically, you should have at least four days a month where your headaches are moderate to severe, and your migraines should have started before the age of 50.

Participants in this study will be randomly assigned to take one of the three medications and will keep a daily headache diary to track their migraine patterns. This will help researchers understand how well each medication works for different individuals. It’s important to note that participants must be willing to continue any current migraine treatments without changes for the first 16 weeks of the study. If you think you might qualify and are interested in helping improve migraine treatment options, this study could be a great opportunity for you!

Gender

ALL

Eligibility criteria

• 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 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:
• • 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.