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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Northern Arizona Healthcare
RECRUITING
Flagstaff
Mayo Clinic Arizona
RECRUITING
Phoenix
California
Clinical Research Institute
RECRUITING
Los Angeles
USC Keck
NOT_YET_RECRUITING
Los Angeles
Florida
Mayo Clinic Florida
NOT_YET_RECRUITING
Jacksonville
Apple Med Research
RECRUITING
Miami
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University St Louis
RECRUITING
St Louis
West Virginia
West Virginia University
RECRUITING
Morgantown
Contact Information
Primary
Michael R Leonard, MDiv
ARZAPTTrial@mayo.edu
480-342-2908
Backup
Dani C Smith, M.S.
Smith.Dani@Mayo.edu
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 1335
Treatments
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 .
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: University of Iowa, AbbVie, Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov