Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study (NCT06972056) | Clinical Trial Compass
RecruitingPhase 4
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
United States1,335 participantsStarted 2025-07-09
Plain-language 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 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 …
What they're measuring
1
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
Timeframe: Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization