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Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

NCT ID: NCT06972056
Registry status: Recruiting
Study type: Interventional
Phase: Phase 4
Sponsor: Mayo Clinic
Conditions: Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

Enrollment: 1335 participants (Estimated).

What is being studied

Intervention: Alcohols
Intervention: Amines
Intervention: Amino Alcohols
Intervention: atogepant
Drug: Atogepant 60 mg
Intervention: Carbohydrates
Intervention: Fructose
Intervention: Hexoses
Intervention: Hydrocarbons
Intervention: Hydrocarbons, Aromatic
Intervention: Hydrocarbons, Cyclic
Intervention: Ketoses
Intervention: Monosaccharides
Intervention: Naphthalenes
Intervention: Organic Chemicals
Intervention: Phenoxypropanolamines
Intervention: Polycyclic Aromatic Hydrocarbons
Intervention: Polycyclic Compounds
Intervention: Propanolamines
Intervention: Propanols
Intervention: Propranolol
Drug: Propranolol 160 mg
Intervention: Sugars
Intervention: Topiramate
Drug: Topiramate 100 mg

Who may be eligible

Ages: 18 Years to 70 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

36 study locations are listed.

Recruiting site status is explicitly provided for 36 locations; 36 are listed as Recruiting.

Countries: United States

Arizona, United States: 2
California, United States: 4
Colorado, United States: 1
Florida, United States: 4
Kansas, United States: 1
Massachusetts, United States: 1
Minnesota, United States: 1
Missouri, United States: 1
Nebraska, United States: 1
Nevada, United States: 1
New Jersey, United States: 1
New York, United States: 3
North Carolina, United States: 5
Ohio, United States: 1
Oregon, United States: 1
Pennsylvania, United States: 1
Rhode Island, United States: 1
Tennessee, United States: 1
Texas, United States: 1
Utah, United States: 1
West Virginia, United States: 1
Wisconsin, United States: 2

Sample of listed locations

Northern Arizona Healthcare — Flagstaff, Arizona, 86001, United States — Recruiting
Mayo Clinic Arizona — Phoenix, Arizona, 85054, United States — Recruiting
Clinical Research Institute — Los Angeles, California, 90048, United States — Recruiting
Keck School of Medicine of USC — Los Angeles, California, 90033, United States — Recruiting
Desert Physicians Medical Group — Palm Springs, California, 92262, United States — Recruiting
The Neurology Group — Pomona, California, 91767, United States — Recruiting
University of Colorado Anschutz Medical Campus — Aurora, Colorado, 80045, United States — Recruiting
Memorial Healthcare — Hollywood, Florida, 33021, United States — Recruiting
Mayo Clinic Florida — Jacksonville, Florida, 32066, United States — Recruiting
Apple Med Research — Miami, Florida, 33126, United States — Recruiting
University of Miami — Miami, Florida, 33136, United States — Recruiting
Neuroscience Research Center — Overland Park, Kansas, 66210, United States — Recruiting
Clinical Trials of New England — Hyde Park, Massachusetts, 02136, United States — Recruiting
Mayo Clinic — Rochester, Minnesota, 55905, United States — Recruiting
Washington University St Louis — St Louis, Missouri, 63110, United States — Recruiting
Nebraska Medical Center — Omaha, Nebraska, 68198, United States — Recruiting
Advanced Research Institute Reno — Reno, Nevada, 89511, United States — Recruiting
JFK Neuroscience Institute — Edison, New Jersey, 08820, United States — Recruiting
Nuvance Health Institute — Kingston, New York, 12401, United States — Recruiting
Northwell Health — Manhasset, New York, 11030, United States — Recruiting
Mt Sinai Icahn School of Medicine — New York, New York, 10029, United States — Recruiting
Onsite Clinical Solutions Ballantyne — Charlotte, North Carolina, 28277, United States — Recruiting
Onsite Clinical Solutions Mecklenburg — Charlotte, North Carolina, 28211, United States — Recruiting
Onsite Clinical Solutions Park Cedar Dr. — Charlotte, North Carolina, 28210, United States — Recruiting
Onsite Clinical Solutions Salisbury — Salisbury, North Carolina, 28144, United States — Recruiting

Study details

Start date: July 9, 2025
Primary completion date: March 1, 2029
Completion date: December 1, 2029
First posted: May 14, 2025
Collaborators: AbbVie, Patient-Centered Outcomes Research Institute, University of Iowa

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06972056
Registry last updated: September 16, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT06972056 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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