RECRUITING

Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2029-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06972056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults, 18-70 years of age at the time of enrollment
  2. * 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.)
  3. * Migraine onset prior to 50 years of age
  4. * Migraine present for at least 12 months at the time of enrollment
  5. * 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.
  6. * 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.
  7. * Not pregnant or breastfeeding
  8. * Women of childbearing potential must agree to use effective methods of contraception to reduce the risk of pregnancy.
  9. * Willingness and ability to provide informed consent.
  10. * Willingness and ability to complete all research visits.
  1. * Contraindications to taking atogepant, propranolol, or topiramate.
  2. * Currently taking atogepant, propranolol, or topiramate\*
  3. * Previously took atogepant, propranolol, or topiramate\*
  4. * Unwillingness to take atogepant, topiramate, or propranolol.
  5. * Current use of a CGRP-targeting preventive medication or beta-blocker
  6. * Migraine with brainstem aura
  7. * Hemiplegic migraine
  8. * Retinal migraine
  9. * Migraine aura without headache (exclusively)
  10. * Pure menstrual migraine
  11. * Trigeminal autonomic cephalalgias
  12. * Facial neuralgias
  13. * Secondary headache disorders (medication overuse headache is not an exclusion)
  14. * Migraine preventive treatment has been started or dose has been changed within 12 weeks prior to potential enrollment.
  15. * Used opioids or butalbital on five or more days per month on average for at least 3 months prior to enrollment.
  16. * Current or past epilepsy
  17. * Severe hepatic impairment
  18. * 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.

Contacts and Locations

Study Contact

Michael R Leonard, MDiv
CONTACT
480-342-2908
ARZAPTTrial@mayo.edu
Dani C Smith, M.S.
CONTACT
Smith.Dani@Mayo.edu

Principal Investigator

Todd J Schwedt, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Northern Arizona Healthcare
Flagstaff, Arizona, 86001
United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Mayo Clinic
Phoenix, Arizona, 85054
United States
USC Keck
Los Angeles, California, 90033
United States
Clinical Research Institute
Los Angeles, California, 90048
United States
Mayo Clinic Florida
Jacksonville, Florida, 32066
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Todd J Schwedt, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2029-12-01

Study Record Updates

Study Start Date2025-07
Study Completion Date2029-12-01

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Migraine with aura
  • Migraine prevention

Additional Relevant MeSH Terms

  • Migraine