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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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
Onsite Clinical Solutions Mecklenburg
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CharlotteUnited StatesRecruiting
Onsite Clinical Solutions Ballantyne
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CharlotteUnited StatesRecruiting
Onsite Clinical Solutions Park Cedar Dr.
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CharlotteUnited StatesRecruiting
Ohio State University Wexner Medical Center
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ColumbusUnited StatesRecruiting
JFK Neuroscience Institute
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EdisonUnited StatesRecruiting
Northern Arizona Healthcare
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FlagstaffUnited StatesRecruiting
Apogee Clinical Research
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Hazel GreenUnited StatesNot yet recruiting
Memorial Healthcare
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HollywoodUnited StatesRecruiting
Clinical Trials of New England
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Hyde ParkUnited StatesRecruiting
Mayo Clinic Florida
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JacksonvilleUnited StatesRecruiting
Nuvance Health Institute
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KingstonUnited StatesRecruiting
Keck School of Medicine of USC
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Los AngelesUnited StatesRecruiting
Clinical Research Institute
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Los AngelesUnited StatesRecruiting
Northwell Health
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ManhassetUnited StatesRecruiting
Marshfield Clinic Research Institute
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MarshfieldUnited StatesRecruiting
DHR Health Headache Center
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McAllenUnited StatesRecruiting
University of Miami
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MiamiUnited StatesRecruiting
Apple Med Research
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MiamiUnited StatesRecruiting
The Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
West Virginia University
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MorgantownUnited StatesRecruiting
Vanderbilt Medical Center
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NashvilleUnited StatesRecruiting
Mt Sinai Icahn School of Medicine
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New YorkUnited StatesRecruiting
Advanced Research Institute Ogden
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OgdenUnited StatesRecruiting
Nebraska Medical Center
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OmahaUnited StatesRecruiting
Neuroscience Research Center
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Overland ParkUnited StatesRecruiting
Desert Physicians Medical Group
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Palm SpringsUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
Mayo Clinic - Arizona
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PhoenixUnited StatesRecruiting
The Neurology Group
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PomonaUnited StatesRecruiting
Advanced Research Institute
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PortlandUnited StatesRecruiting
Brown University Health
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ProvidenceUnited StatesRecruiting
Advanced Research Institute - Reno
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RenoUnited StatesRecruiting
Mayo Clinic
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RochesterUnited StatesRecruiting
Onsite Clinical Solutions Salisbury
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SalisburyUnited StatesRecruiting
Washington University St. Louis
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St LouisUnited StatesRecruiting
Wake Forest University Health
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.