RECRUITING Phase 4 ClinicalTrials.gov

Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT06972056

Registry updated: 2026-10-19

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Atogepant 60 mg (Drug)
Atogepant at a dose up to 60 mg daily.
Propranolol 160 mg (Drug)
Daily propranolol up to 80 mg twice daily.
Topiramate 100 mg (Drug)
Daily topiramate, up to 50 mg twice daily

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.

Conditions

Migraine

Locations

Apogee Clinical Research — Hazel Green, Alabama, United States
Northern Arizona Healthcare — Flagstaff, Arizona, United States
Mayo Clinic Arizona — Phoenix, Arizona, United States
Keck School of Medicine of USC — Los Angeles, California, United States
Clinical Research Institute — Los Angeles, California, United States
Desert Physicians Medical Group — Palm Springs, California, United States
The Neurology Group — Pomona, California, United States
University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
Memorial Healthcare — Hollywood, Florida, United States
Mayo Clinic Florida — Jacksonville, Florida, United States
Apple Med Research — Miami, Florida, United States
University of Miami — Miami, Florida, United States
Neuroscience Research Center — Overland Park, Kansas, United States
Clinical Trials of New England — Hyde Park, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University St Louis — St Louis, Missouri, United States
Nebraska Medical Center — Omaha, Nebraska, United States
Advanced Research Institute Reno — Reno, Nevada, United States
JFK Neuroscience Institute — Edison, New Jersey, United States
Nuvance Health Institute — Kingston, New York, United States
Northwell Health — Manhasset, New York, United States
Mt Sinai Icahn School of Medicine — New York, New York, United States
Onsite Clinical Solutions Park Cedar Dr. — Charlotte, North Carolina, United States
Onsite Clinical Solutions Mecklenburg — Charlotte, North Carolina, United States
Onsite Clinical Solutions Ballantyne — Charlotte, North Carolina, United States
Onsite Clinical Solutions Salisbury — Salisbury, North Carolina, United States
Wake Forest University Health — Winston-Salem, North Carolina, United States
Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Advanced Research Institute — Portland, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Brown University Health — Providence, Rhode Island, United States
Vanderbilt Medical Center — Nashville, Tennessee, United States
DHR Health Headache Center — McAllen, Texas, United States
Advanced Research Institute Ogden — Ogden, Utah, United States
West Virginia University — Morgantown, West Virginia, United States
Marshfield Clinic Research Institute — Marshfield, Wisconsin, United States
The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment