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Updated May 2026 · ClinicalTrials.gov

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

Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study (NCT06972056) is a Phase 4 interventional studying Migraine, sponsored by Mayo Clinic. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,335 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06972056), the sponsor (Mayo Clinic), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06972056 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06972056?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06972056?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06972056. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06972056. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.