Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
Recruiting · NCT06972056 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Atogepant 60 mgPropranolol 160 mgTopiramate 100 mg
What this trial is about
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 take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
36 locations listed across 22 US 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