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NCT06972056PHASE4Recruiting

Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Mayo Clinic

Start Date

7/9/2025

Completion Date

12/1/2029

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.

Detailed Description

This is a prospective, randomized, comparative effectiveness clinical trial of atogepant, propranolol, and topiramate for the prevention of migraine in adults. Eligible participants will provide information in a daily headache diary for four weeks. If after those four weeks they are still eligible for the study, they will be randomized to one of the study medications and receive study medication for twelve weeks. Research visits occur at baseline, four weeks later for the randomization visit, and then at post-randomization weeks four, eight, twelve, twenty-four, and forty-eight. Participants provide data using a headache diary (first 16 weeks of the study) and during research visits. The primary endpoint is the proportion of participants in each treatment group who are "treatment responders" defined as completing the first twelve weeks of the study on the assigned medication and having a 50% or greater reduction in moderate severe headache days during weeks 9-12 post-randomization compared to the four weeks pre-randomization.

Eligibility Criteria

Age Range: 18 years to 70 years

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.

Interventions

DRUG

Atogepant 60 mg

DRUG

Propranolol 160 mg

DRUG

Topiramate 100 mg

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Conditions

Migraine

Locations

Northern Arizona Healthcare

Flagstaff, Arizona 86001

United States

Mayo Clinic Arizona

Phoenix, Arizona 85054

United States

Keck School of Medicine of USC

Los Angeles, California 90033

United States

Clinical Research Institute

Los Angeles, California 90048

United States

Desert Physicians Medical Group

Palm Springs, California 92262

United States

The Neurology Group

Pomona, California 91767

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Memorial Healthcare

Hollywood, Florida 33021

United States

Mayo Clinic Florida

Jacksonville, Florida 32066

United States

Apple Med Research

Miami, Florida 33126

United States

University of Miami

Miami, Florida 33136

United States

Neuroscience Research Center

Overland Park, Kansas 66210

United States

Clinical Trials of New England

Hyde Park, Massachusetts 02136

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University St Louis

St Louis, Missouri 63110

United States

Nebraska Medical Center

Omaha, Nebraska 68198

United States

Advanced Research Institute Reno

Reno, Nevada 89511

United States

JFK Neuroscience Institute

Edison, New Jersey 08820

United States

Nuvance Health Institute

Kingston, New York 12401

United States

Northwell Health

Manhasset, New York 11030

United States

Mt Sinai Icahn School of Medicine

New York, New York 10029

United States

Onsite Clinical Solutions Park Cedar Dr.

Charlotte, North Carolina 28210

United States

Onsite Clinical Solutions Mecklenburg

Charlotte, North Carolina 28211

United States

Onsite Clinical Solutions Ballantyne

Charlotte, North Carolina 28277

United States

Onsite Clinical Solutions Salisbury

Salisbury, North Carolina 28144

United States

Wake Forest University Health

Winston-Salem, North Carolina 27157

United States

Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Advanced Research Institute

Portland, Oregon 97223

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19107

United States

Brown University Health

Providence, Rhode Island 02903

United States

Vanderbilt Medical Center

Nashville, Tennessee 37215

United States

DHR Health Headache Center

McAllen, Texas 78504

United States

Advanced Research Institute Ogden

Ogden, Utah 84405

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Marshfield Clinic Research Institute

Marshfield, Wisconsin 54449

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States