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Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

RecruitingPhase 4

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

Who can join

Ages 18 to 70 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Mayo Clinic · Participants: 1,335 · Started: Jul 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06972056

Locations in the U.S.

ArizonaNorthern Arizona Healthcare, Flagstaff
Mayo Clinic Arizona, Phoenix
CaliforniaClinical Research Institute, Los Angeles
Keck School of Medicine of USC, Los Angeles
Desert Physicians Medical Group, Palm Springs
The Neurology Group, Pomona
ColoradoUniversity of Colorado Anschutz Medical Campus, Aurora
FloridaMemorial Healthcare, Hollywood
Mayo Clinic Florida, Jacksonville
Apple Med Research, Miami
University of Miami, Miami
KansasNeuroscience Research Center, Overland Park
MassachusettsClinical Trials of New England, Hyde Park
MinnesotaMayo Clinic, Rochester
MissouriWashington University St Louis, St Louis
NebraskaNebraska Medical Center, Omaha
NevadaAdvanced Research Institute Reno, Reno
New JerseyJFK Neuroscience Institute, Edison
New YorkNuvance Health Institute, Kingston
Northwell Health, Manhasset
Mt Sinai Icahn School of Medicine, New York
North CarolinaOnsite Clinical Solutions Ballantyne, Charlotte
Onsite Clinical Solutions Mecklenburg, Charlotte
Onsite Clinical Solutions Park Cedar Dr., Charlotte
Onsite Clinical Solutions Salisbury, Salisbury
Wake Forest University Health, Winston-Salem
OhioOhio State University Wexner Medical Center, Columbus
OregonAdvanced Research Institute, Portland
PennsylvaniaUniversity of Pennsylvania, Philadelphia
Rhode IslandBrown University Health, Providence
TennesseeVanderbilt Medical Center, Nashville
TexasDHR Health Headache Center, McAllen
UtahAdvanced Research Institute Ogden, Ogden
West VirginiaWest Virginia University, Morgantown
WisconsinMarshfield Clinic Research Institute, Marshfield
The Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.