Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
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
Interventions
Atogepant 60 mg
Propranolol 160 mg
Topiramate 100 mg
Conditions
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