MigrainePhase 4NCT06972056
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
A Phase 4 study testing Atogepant 60 mg, Propranolol 160 mg and Topiramate 100 mg in people with Migraine, run by Mayo Clinic at 37 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- What is being tested?
- Atogepant 60 mg, Propranolol 160 mg and Topiramate 100 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,335 participants
- Where
- 37 sitesUnited States
- Study dates
- 9 Jul 2025to 1 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dani C Smith, M.S. contact
37 sites in 1 country
United States37 sites, 37 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Adam Angelich, 303-724-5923, adam.angelich@cuanschutz.edu
Trey Jouard, 303-724-0920, TREY.JOUARD@CUANSCHUTZ.EDU
- Recruiting
Onsite Clinical Solutions Park Cedar Dr.
Charlotte, North Carolina, 28210
Zoe Landingin, 800-785-3150 ext. 1130, zlandingin@onsiteclinical.com
Summer Evans, 800-785-3150 ext. 1034, Sevans@onsiteclinical.com
- Recruiting
Onsite Clinical Solutions Mecklenburg
Charlotte, North Carolina, 28211
Megan Hazlitt, 800-785-3150 ext. 1002, mhazlitt@onsiteclinical.com
Alexis Adams, 800-785-3150 ext. 1198, aadams@onsiteclinical.com
- Recruiting
Onsite Clinical Solutions Ballantyne
Charlotte, North Carolina, 28277
Summer Evans, 800-785-3150 ext. 1068, Sevans@onsiteclinical.com
Steph Alvarado, 800-785-3150 ext. 1034, salvarado@onsiteclinical.com
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Kemba Johnson, 614-293-8000, Kemba.Johnson@osumc.edu
Kevin Weber, MD
- Recruiting
JFK Neuroscience Institute
Edison, New Jersey, 08820
Priyanka Basnet, BSN, RN, 732-321-7010, priyanka.basnet@hmhn.org
Shriya Patel, shp228@lehigh.edu
- Recruiting
Northern Arizona Healthcare
Flagstaff, Arizona, 86001
Julie Kenkel, RN, 928-779-3366, Julie.Kenkel@nahealth.com
Justin DeLange, D.O.
- Not yet recruiting
Apogee Clinical Research
Hazel Green, Alabama, 35750
Shelby Lessman, 256-827-5050, slessmann@apogeecr.com
Jesslyn Roesch, 256-827-5050, jroesch@apogeecr.com
- Recruiting
Memorial Healthcare
Hollywood, Florida, 33021
Elisa Serantes, 954 265-4184, elserantes@mhs.net
Piret Baldwin, 954-265-6653, Pibaldwin@mhs.net
- Recruiting
Clinical Trials of New England
Hyde Park, Massachusetts, 02136
Kenny Carberry, 617-827-1803, KCarberry@ClinicalTrialsNE.com
Wonji Shin, WShin@clinicaltrialsne.com
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32066
Tinsae Dana, 904-953-4259, Dana.Tinsae@mayo.edu
TInsae Dana, Dana.Tinsae@mayo.edu
- Recruiting
Nuvance Health Institute
Kingston, New York, 12401
Rishitha Thanikonda, 845-790-5848 ext. 51256, rishitha.thanikonda@nuvancehealth.org
Olatunde Olaniyi, 845-790-5848 ext. 51256, olatunde.olaniyi@nuvancehealth.org
- Recruiting
Keck School of Medicine of USC
Los Angeles, California, 90033
Rama Koppula, 323-865-1020, rk_198@usc.edu
Soma Sahai-Srivastava, MD
- Recruiting
Clinical Research Institute
Los Angeles, California, 90048
Ana Duchenko, 323-879-9999, aduchenko@clinicalri.net
Sandy Velasquez, 323-879-9999, svelasquez@clinicalri.net
- Recruiting
Northwell Health
Manhasset, New York, 11030
Carmen Lima, 516-472-5807, clima5@northwell.edu
Nicholas Zumba, 516-319-7654, nzumba@northwell.edu
- Recruiting
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449
Megan Johnson, 715-389-5473, johnson.megan.a@marshfieldresearch.org
Stacy Welter, 715-221-6492, welter.stacy@marshfieldresearch.org
- Recruiting
DHR Health Headache Center
McAllen, Texas, 78504
Leah Picazo, 956-362-2234, Leah.Picazo@dhrhealth.com
Alexis Valencia, Alexis.Valencia@dhrhealth.com
- Recruiting
Apple Med Research
Miami, Florida, 33126
Carlos M Manzano, 305-667-8434, c26applemed@aol.com
Lillibeth Paz, 305-667-8434, l.paz@applemedresearch.org
- Recruiting
University of Miami
Miami, Florida, 33136
Lilli Resto, 305-243-1485, Lxr1013@miami.edu
Daniella Estevez, 305-243-1485, d.estevez1@miami.edu
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Karen Schmidt, RN, (414) 955-0674, kaschmidt@mcw.edu
Victoria Ochotnicky, (414) 955-0659, vochotnicky@mcw.edu
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Lauren Chase RN, BSN, 304-598-4000 ext. 79418, lauren.chase@wvumedicine.org
Bethany Moore, RPh, Bethany.moore2@wvumedicine.org
- Recruiting
Vanderbilt Medical Center
Nashville, Tennessee, 37215
Jordon Winn, 615-421-6094, Jordon.winn@vumc.org
Joy Derwenskus, MD
- Recruiting
Mt Sinai Icahn School of Medicine
New York, New York, 10029
Sarah Kurtz, PA-C, 917-273-1674, sarah.kurtz@mssm.edu
Maya Campbell, Maya.campbell@mssm.edu
- Recruiting
Advanced Research Institute Ogden
Ogden, Utah, 84405
Stephanie Church, 801-409-2040, stephanie@advresearch.org
Noah Nielsen, 801-409-2040, noah@advresearch.org
- Recruiting
Nebraska Medical Center
Omaha, Nebraska, 68198
Jana Ocken, 402-552-2672, jocken@unmc.edu
Morgan Hurtz, 402-552-6233, mhurtz@unmc.edu
- Recruiting
Neuroscience Research Center
Overland Park, Kansas, 66210
Amy Reinert, (913) 825-2314, amy.r@neuroscienceresearchctr.com
Neda Ahmad, (913) 825-2315, neda.a@neuroscienceresearchctr.com
- Recruiting
Desert Physicians Medical Group
Palm Springs, California, 92262
Cindy Ramirez, 760-459-2193, cindy@dpmgcr.com
Dario Kuzmanovic, 909-547-7178, dario.kuzmanovic@dpmghealth.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Gina Siermine, 215-829-5159, Gina.Siermine@PennMedicine.upenn.edu
Allie Oliver, 215-829-7104, Alexandria.Oliver@pennmedicine.upenn.edu
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Dani C Smith, MS, 480-342-6524, Smith.Dani@Mayo.edu
Michael Leonard, MDiv, 480-342-2908, Leonard.Michael@Mayo.edu
- Recruiting
The Neurology Group
Pomona, California, 91767
Ikram Rfifa, BS, 951-768-2352, ikram@amctrials.com
Sheraz Mossa, BS, 858-761-1090, Sheraz@amctrials.com
- Recruiting
Advanced Research Institute
Portland, Oregon, 97223
Jessica Weed, 503-610-0033, jessicaw@advresearch.org
Rachael Widner, 503-610-0033, rachael@advresearch.org
- Recruiting
Brown University Health
Providence, Rhode Island, 02903
Deepica Chaudhary, 401-606-4655, DChaudhary@brownhealth.org
Alexis DeMarco, 401-606-4651, ADemarco@brownhealth.org
- Recruiting
Advanced Research Institute Reno
Reno, Nevada, 89511
Amber Thaxton, 775-502-1616, amber@advresearch.org
Matthew Mehlhaff, 877-577-3732, matt@advresearch.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Terrell Rieken, 507-422-6561, rieken.terrell@mayo.edu
Izzie Meunier, 507-538-6337, Headlee.Amy@mayo.edu
- Recruiting
Onsite Clinical Solutions Salisbury
Salisbury, North Carolina, 28144
Amanda Groce, 800-785-3150 ext. 1209, agroce@onsiteclinical.com
Mandy Grice, 800-785-3150 ext. 1210, mgrice@onsiteclinical.com
- Recruiting
Washington University St Louis
St Louis, Missouri, 63110
Alyssa Hiserote, calyssa@wustl.edu
Angela Wolford, angelaw@wustl.edu
- Recruiting
Wake Forest University Health
Winston-Salem, North Carolina, 27157
Lauren Middleton, 336-713-2748, Lauren.Middleton@Advocatehealth.org
Janet Hutchens, 336-716-1715, Janet.Hutchens@Advocatehealth.org
About this study
Official title: A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Atogepant 60 mg, Propranolol 160 mg, Topiramate 100 mg
- Keywords
- Migraine, Migraine with aura, Migraine prevention
- Medical subject headings
- Migraine Disorders, Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atogepant 60 mgDrug
Also called Qulipta
Atogepant at a dose up to 60 mg daily.
Propranolol 160 mgDrug
Also called Inderal
Daily propranolol up to 80 mg twice daily.
Topiramate 100 mgDrug
Also called Topamax
Daily topiramate, up to 50 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Atogepant | Active comparator | Participants who are randomized to this arm will take up to 60mg daily for 12 weeks. Receives: Drug: Atogepant 60 mg |
| Propranolol | Active comparator | Participants randomized to this arm will take up to 160 mg daily for 12 weeks. Receives: Drug: Propranolol 160 mg |
| Topiramate | Active comparator | Participants randomized to this arm will take up to 100 mg daily for 12 weeks . Receives: Drug: Topiramate 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as:
- Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND
- Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
Measured: Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization
Secondary outcomes (4)
Migraine Specific Quality-of-Life - Role Function-Restrictive
The role function-restrictive domain of the Migraine Specific Quality of Life questionnaire is a 7-item valid measure of functional impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness during the past four weeks.
Measured: Week 12 post-randomization vs. baseline
Treatment Responder (propranolol vs. topiramate)
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as:
- Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND
- Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
Measured: Weeks 9-12 post-randomization vs. the 4 weeks prior to randomization
Headache Impact Test-6 (HIT-6)
The HIT-6 is a six-item questionnaire that measures the impact headaches have on a person's ability to function on the job, at home, at school, and in social situations.
Measured: week 12 post-randomization vs. baseline
Medication-Related Adverse Events
This medication-related adverse event outcome will consist of all adverse events that are deemed to be at least possibly related to the study medication.
Measured: All 12 weeks of the randomized treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start9 Jul 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Patient-Centered Outcomes Research Institute, AbbVie
- Responsible party
- Principal investigator, Todd J. Schwedt, Mayo Clinic
- Investigators
- Todd J Schwedt, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972056
- Sponsor's protocol ID
- 24-012753
- Other IDs
- MI-2023C2-33021
- Status last verified
- May 2026
- First submitted
- 29 Apr 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: As per PCORI data sharing policy
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study
- ClinicalTrials.gov ID
- NCT06972056
- Acronym / sponsor ID
- 24-012753
- Conditions
- Migraine
- Keywords
- Migraine, Migraine with aura, Migraine prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,335 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Iowa, Patient-Centered Outcomes Research Institute, AbbVie
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atogepant | Active comparator | Drug: Atogepant 60 mgParticipants who are randomized to this arm will take up to 60mg daily for 12 weeks. |
| Propranolol | Active comparator | Drug: Propranolol 160 mgParticipants randomized to this arm will take up to 160 mg daily for 12 weeks. |
| Topiramate | Active comparator | Drug: Topiramate 100 mgParticipants randomized to this arm will take up to 100 mg daily for 12 weeks . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atogepant 60 mgAlso: QuliptaAtogepant at a dose up to 60 mg daily. | Drug | Atogepant |
| Propranolol 160 mgAlso: InderalDaily propranolol up to 80 mg twice daily. | Drug | Propranolol |
| Topiramate 100 mgAlso: TopamaxDaily topiramate, up to 50 mg twice daily | Drug | Topiramate |
Primary outcome
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
Time frame: Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as: 1. Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND 2. Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
4 secondary outcomes
Migraine Specific Quality-of-Life - Role Function-Restrictive
Time frame: Week 12 post-randomization vs. baseline
Treatment Responder (propranolol vs. topiramate)
Time frame: Weeks 9-12 post-randomization vs. the 4 weeks prior to randomization
Headache Impact Test-6 (HIT-6)
Time frame: week 12 post-randomization vs. baseline
Medication-Related Adverse Events
Time frame: All 12 weeks of the randomized treatment phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. As per PCORI data sharing policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dani C Smith, M.S. contact
Todd J Schwedt, M.D. principal investigator
Mayo Clinic
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atogepant 60 mg, Propranolol 160 mg and Topiramate 100 mg in people with Migraine, run by Mayo Clinic at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael R Leonard, MDiv (480-342-2908, ARZAPTTrial@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol) (time frame: Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.