RECRUITINGPhase 4INTERVENTIONAL
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
- Willingness and ability to complete all research visits.
Who Should NOT Join This Trial:
- 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)
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Atogepant 60 mg
Atogepant at a dose up to 60 mg daily.
DRUG
Propranolol 160 mg
Daily propranolol up to 80 mg twice daily.
DRUG
Topiramate 100 mg
Daily topiramate, up to 50 mg twice daily
Locations (20)
Northern Arizona Healthcare
Flagstaff, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
USC Keck
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
Mayo Clinic Florida
Jacksonville, Florida, United States
Apple Med Research
Miami, Florida, 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
Advanced Research Institute Reno
Reno, Nevada, United States
JFK Neuroscience Institute
Edison, New Jersey, United States
Nuvance Health Institute
Kingston, New York, 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
Vanderbilt Medical Center
Nashville, Tennessee, United States