Recruiting

Atogepant, Topiramate, PropranololComparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Sponsor:

Mayo Clinic

Code:

NCT06972056

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Atogepant 60 mg

Propranolol 160 mg

Topiramate 100 mg

Study Details

Brief 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.

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.

Conditions

Migraine

Study ID

NCT06972056

Start date

Jul 9, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1335 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Atogepant

Participants who are randomized to this arm will take up to 60mg daily for 12 weeks.

active comparator: Propranolol

Participants randomized to this arm will take up to 160 mg daily for 12 weeks.

active comparator: Topiramate

Participants randomized to this arm will take up to 100 mg daily for 12 weeks .

Interventions

Atogepant 60 mg

Atogepant at a dose up to 60 mg daily.

Propranolol 160 mg

Daily propranolol up to 80 mg twice daily.

Topiramate 100 mg

Daily topiramate, up to 50 mg twice daily

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 ]

Central Contacts and Locations

Central contacts

Michael R Leonard, MDiv

480-342-2908 ARZAPTTrial@mayo.edu

Dani C Smith, M.S.

Smith.Dani@Mayo.edu

Locations

Northern Arizona Healthcare

Recruiting

Flagstaff, Arizona, United States, 86001

Contacts

Julie Kenkel, RN

928-779-3366 Julie.Kenkel@nahealth.com

Principal Investigator:

Justin DeLange, D.O.

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Dani C Smith, MS

480-342-6524 Smith.Dani@Mayo.edu

Michael Leonard, MDiv

480-342-2908 Leonard.Michael@Mayo.edu

Principal Investigator:

Todd Schwedt, MD

Keck School of Medicine of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Rama Koppula

323-442-6021 rk_198@usc.edu

Principal Investigator:

Soma Sahai-Srivastava, MD

Clinical Research Institute

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ana Duchenko

323-879-9999 aduchenko@clinicalri.net

Sandy Velasquez

323-879-9999 svelasquez@clinicalri.net

Principal Investigator:

David Kudrow, MD

Desert Physicians Medical Group

Recruiting

Palm Springs, California, United States, 92262

Contacts

Alma Wilcox

909-547-7178 alma@dpmgcr.com

Dario Kuzmanovic

909-547-7178 dario.kuzmanovic@dpmghealth.com

Principal Investigator:

Gemma Kim, MD

The Neurology Group

Recruiting

Pomona, California, United States, 91767

Contacts

Ikram Rfifa, BS

951-768-2352 ikram@amctrials.com

Sheraz Mossa, BS

858-761-1090 Sheraz@amctrials.com

Principal Investigator:

Samer Kebbeh, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Adam Angelich

303-724-5923 adam.angelich@cuanschutz.edu

Trey Jouard

303-724-0920 TREY.JOUARD@CUANSCHUTZ.EDU

Principal Investigator:

Nicole Caunt, MD

Memorial Healthcare

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Elisa Serantes

954 265-4184 elserantes@mhs.net

Piret Baldwin

954-265-6653 Pibaldwin@mhs.net

Principal Investigator:

Maike Blaya, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32066

Contacts

Tinsae Dana

904-953-4259 Dana.Tinsae@mayo.edu

TInsae Dana

Dana.Tinsae@mayo.edu

Principal Investigator:

Olga Fermo, MD

Apple Med Research

Recruiting

Miami, Florida, United States, 33126

Contacts

Carlos M Manzano

305-667-8434 c26applemed@aol.com

Lillibeth Paz

305-667-8434 l.paz@applemedresearch.org

Principal Investigator:

Agustin L Latorre, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Lilli Resto

305-243-1485 Lxr1013@miami.edu

Daniella Estevez

305-243-1485 d.estevez1@miami.edu

Principal Investigator:

Teshamae Monteith, MD

Neuroscience Research Center

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Amy Reinert

(913) 825-2314 amy.r@neuroscienceresearchctr.com

Neda Ahmad

(913) 825-2315 neda.a@neuroscienceresearchctr.com

Principal Investigator:

Mayank Gupta, MD

Clinical Trials of New England

Recruiting

Hyde Park, Massachusetts, United States, 02136

Contacts

Kenny Carberry

617-827-1803 KCarberry@ClinicalTrialsNE.com

Principal Investigator:

Michael Lowney, DO

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Charles Mason

507-284-1223 mason.charles@mayo.edu

Izzie Meunier

507-538-6337 Headlee.Amy@mayo.edu

Principal Investigator:

Chia-Chun Chiang, MD

Washington University St Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alyssa Hiserote

calyssa@wustl.edu

Angela Wolford

angelaw@wustl.edu

Principal Investigator:

Rachel Darken, MD

Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Jana Ocken

402-552-6246 jocken@unmc.edu

Morgan Hurtz

402-552-6246 mhurtz@unmc.edu

Principal Investigator:

Beth Hartman, MD

Advanced Research Institute Reno

Recruiting

Reno, Nevada, United States, 89511

Contacts

Amber Thaxton

775-502-1616 amber@advresearch.org

Matthew Mehlhaff

877-577-3732 matt@advresearch.org

Principal Investigator:

Dennis T. Yamamoto, MD

JFK Neuroscience Institute

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Regil Varghese

732-321-7000 regil.varghese@hmhn.org

Aksa Saju

aksa.saju@hmhn.org

Principal Investigator:

Brian Gerhardstein, MD

Nuvance Health Institute

Recruiting

Kingston, New York, United States, 12401

Contacts

Rishitha Thanikonda

845-790-5848 rishitha.thanikonda@nuvancehealth.org

Olatunde Olaniyi

845-790-5848 olatunde.olaniyi@nuvancehealth.org

Principal Investigator:

Julio Vieira, MD

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Carmen Lima

516-472-5807 clima5@northwell.edu

Nicholas Zumba

516-319-7654 nzumba@northwell.edu

Principal Investigator:

Noah Rosen, MD

Mt Sinai Icahn School of Medicine

Recruiting

New York, New York, United States, 10029

Contacts

Maya Campbell

(603) 502-5562 Maya.campbell@mssm.edu

Kaitlyn Coyle

kaitlyn.coyle@mssm.edu

Principal Investigator:

Bridget Mueller, MD

Onsite Clinical Solutions Park Cedar Dr.

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

Zoe Landingin

800-785-3150 zlandingin@onsiteclinical.com

Ryans Bills

800-785-3150 rbills@onsiteclinical.com

Principal Investigator:

Kenneth Ashkin, MD

Onsite Clinical Solutions Mecklenburg

Recruiting

Charlotte, North Carolina, United States, 28211

Contacts

Megan Hazlitt

800-785-3150 mhazlitt@onsiteclinical.com

Alexis Adams

800-785-3150 aadams@onsiteclinical.com

Principal Investigator:

George Raad, MD

Onsite Clinical Solutions Ballantyne

Recruiting

Charlotte, North Carolina, United States, 28277

Contacts

Summer Evans

800-785-3150 Sevans@onsiteclinical.com

Ryan Bills

800-785-3150 rbills@onsiteclinical.com

Principal Investigator:

Steven Bauer, MD

Onsite Clinical Solutions Salisbury

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Amanda Groce

800-785-3150 agroce@onsiteclinical.com

Mandy Grice

800-785-3150 mgrice@onsiteclinical.com

Principal Investigator:

Douglas Shellhorn, MD

Wake Forest University Health

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Timothy Gilliam, RN

336- 713-3861 Timothy.Gilliam@Advocatehealth.org

Lauren Middleton

336-713-2748 Lauren.Middleton@Advocatehealth.org

Principal Investigator:

Barbara Nye, MD

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kemba Johnson

614-293-8000 Kemba.Johnson@osumc.edu

Principal Investigator:

Kevin Weber, MD

Advanced Research Institute

Recruiting

Portland, Oregon, United States, 97223

Contacts

Jessica Weed

503-610-0033 jessicaw@advresearch.org

Rachael Widner

503-610-0033 rachael@advresearch.org

Principal Investigator:

Walter Goebel, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Gina Siermine

215-829-5159 Gina.Siermine@PennMedicine.upenn.edu

Allie Oliver

215-829-7104 Alexandria.Oliver@pennmedicine.upenn.edu

Principal Investigator:

Eric Kaiser, MD

Brown University Health

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Deepica Chaudhary

401-606-4655 DChaudhary@brownhealth.org

Alexis DeMarco

401-606-4651 ADemarco@brownhealth.org

Principal Investigator:

Roderick Spears, MD

Vanderbilt Medical Center

Recruiting

Nashville, Tennessee, United States, 37215

Contacts

Jordon Winn

615-421-6094 Jordon.winn@vumc.org

Principal Investigator:

Joy Derwenskus, MD

DHR Health Headache Center

Recruiting

McAllen, Texas, United States, 78504

Contacts

Leah Picazo

956-362-2234 Leah.Picazo@dhrhealth.com

Alexis Valencia

Alexis.Valencia@dhrhealth.com

Principal Investigator:

Gloria Simms, MD

Advanced Research Institute Ogden

Recruiting

Ogden, Utah, United States, 84405

Contacts

Stephanie Church

801-409-2040 stephanie@advresearch.org

Noah Nielsen

801-409-2040 noah@advresearch.org

Principal Investigator:

Michael Woolman, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Lauren Chase RN, BSN

304-598-4000 lauren.chase@wvumedicine.org

Bethany Moore, RPh

Bethany.moore2@wvumedicine.org

Principal Investigator:

Kristina Lopez, MD

Marshfield Clinic Research Institute

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Megan Johnson

715-389-5473 johnson.megan.a@marshfieldresearch.org

Stacy Welter

715-221-6492 welter.stacy@marshfieldresearch.org

Principal Investigator:

Jeff VanWormer, PhD

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Karen Schmidt, RN

(414) 955-0674 kaschmidt@mcw.edu

Victoria Ochotnicky

(414) 955-0659 vochotnicky@mcw.edu

Principal Investigator:

Glen Soloman, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 30, 2026

Last verified

May, 2026

Keywords

Migraine
Migraine with aura
Migraine prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-30.