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
2 other identifiers
interventional
1,335
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2025
Longer than P75 for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
July 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
May 22, 2026
May 1, 2026
3.6 years
April 29, 2025
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization
Secondary Outcomes (4)
Migraine Specific Quality-of-Life - Role Function-Restrictive
Week 12 post-randomization vs. baseline
Treatment Responder (propranolol vs. topiramate)
Weeks 9-12 post-randomization vs. the 4 weeks prior to randomization
Headache Impact Test-6 (HIT-6)
week 12 post-randomization vs. baseline
Medication-Related Adverse Events
All 12 weeks of the randomized treatment phase
Study Arms (3)
Atogepant
ACTIVE COMPARATORParticipants who are randomized to this arm will take up to 60mg daily for 12 weeks.
Propranolol
ACTIVE COMPARATORParticipants randomized to this arm will take up to 160 mg daily for 12 weeks.
Topiramate
ACTIVE COMPARATORParticipants randomized to this arm will take up to 100 mg daily for 12 weeks .
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- University of Iowacollaborator
- Patient-Centered Outcomes Research Institutecollaborator
- AbbViecollaborator
Study Sites (35)
Northern Arizona Healthcare
Flagstaff, Arizona, 86001, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
USC Keck
Los Angeles, California, 90033, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
Desert Physicians Medical Group
Palm Springs, California, 92262, United States
The Neurology Group
Pomona, California, 91767, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Memorial Healthcare
Hollywood, Florida, 33021, United States
Mayo Clinic Florida
Jacksonville, Florida, 32066, United States
Apple Med Research
Miami, Florida, 33126, United States
University of Miami
Miami, Florida, 33136, United States
Clinical Trials of New England
Hyde Park, Massachusetts, 02136, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University St Louis
St Louis, Missouri, 63110, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Advanced Research Institute Reno
Reno, Nevada, 89511, United States
JFK Neuroscience Institute
Edison, New Jersey, 08820, United States
Nuvance Health Institute
Kingston, New York, 12401, United States
Northwell Health
Manhasset, New York, 11030, United States
Mt Sinai Icahn School of Medicine
New York, New York, 10029, United States
Onsite Clinical Solutions Park Cedar Dr.
Charlotte, North Carolina, 28210, United States
Onsite Clinical Solutions Mecklenburg
Charlotte, North Carolina, 28211, United States
Onsite Clinical Solutions Ballantyne
Charlotte, North Carolina, 28277, United States
Onsite Clinical Solutions Salisbury
Salisbury, North Carolina, 28144, United States
Wake Forest University Health
Winston-Salem, North Carolina, 27157, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Advanced Research Institute
Portland, Oregon, 97223, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Brown University Health
Providence, Rhode Island, 02903, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37215, United States
DHR Health Headache Center
McAllen, Texas, 78504, United States
Advanced Research Institute Ogden
Ogden, Utah, 84405, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd J Schwedt, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 14, 2025
Study Start
July 9, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Summer 2030 (anticipated)
- Access Criteria
- Per PCORI data sharing policy
As per PCORI data sharing policy