NCT06972056RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1335 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 9 Jul 2025
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- Mayo Clinic
- Diseases
- Migraine
- NCT number
- NCT06972056
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1335
- From 9 Jul 2025 to the primary completion date, 1 Mar 2029
- 37 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking atogepant, propranolol, or topiramate\*
- Previously took atogepant, propranolol, or topiramate\*
- Current use of a CGRP-targeting preventive medication or beta-blocker
- 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.
Other illness
- Secondary headache disorders (medication overuse headache is not an exclusion)
- 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.
Other
- Contraindications to taking atogepant, propranolol, or topiramate.
- Unwillingness to take atogepant, topiramate, or propranolol.
- Migraine with brainstem aura
- Hemiplegic migraine
- Retinal migraine
- Migraine aura without headache (exclusively)
- Pure menstrual migraine
- Trigeminal autonomic cephalalgias
- Facial neuralgias
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Onsite Clinical Solutions Mecklenburg Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Onsite Clinical Solutions Ballantyne Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Onsite Clinical Solutions Park Cedar Dr. Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Ohio State University Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| JFK Neuroscience Institute Coordinator of this site? Confirm its status | Edison | United States | Recruiting |
| Northern Arizona Healthcare Coordinator of this site? Confirm its status | Flagstaff | United States | Recruiting |
| Apogee Clinical Research Coordinator of this site? Confirm its status | Hazel Green | United States | Not yet recruiting |
| Memorial Healthcare Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Clinical Trials of New England Coordinator of this site? Confirm its status | Hyde Park | United States | Recruiting |
| Mayo Clinic Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Nuvance Health Institute Coordinator of this site? Confirm its status | Kingston | United States | Recruiting |
| Keck School of Medicine of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Clinical Research Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Northwell Health Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
| Marshfield Clinic Research Institute Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| DHR Health Headache Center Coordinator of this site? Confirm its status | McAllen | United States | Recruiting |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Apple Med Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| The Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Vanderbilt Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Mt Sinai Icahn School of Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Advanced Research Institute Ogden Coordinator of this site? Confirm its status | Ogden | United States | Recruiting |
| Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Neuroscience Research Center Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Desert Physicians Medical Group Coordinator of this site? Confirm its status | Palm Springs | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| The Neurology Group Coordinator of this site? Confirm its status | Pomona | United States | Recruiting |
| Advanced Research Institute Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Brown University Health Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| Advanced Research Institute - Reno Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Onsite Clinical Solutions Salisbury Coordinator of this site? Confirm its status | Salisbury | United States | Recruiting |
| Washington University St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Wake Forest University Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.