NCT06972056

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,335 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, comparative effectiveness clinical trial of atogepant, propranolol, and topiramate for the prevention of migraine in adults. Eligible participants will provide information in a daily headache diary for four weeks. If after those four weeks they are still eligible for the study, they will be randomized to one of the study medications and receive study medication for twelve weeks. Research visits occur at baseline, four weeks later for the randomization visit, and then at post-randomization weeks four, eight, twelve, twenty-four, and forty-eight. Participants provide data using a headache diary (first 16 weeks of the study) and during research visits. The primary endpoint is the proportion of participants in each treatment group who are "treatment responders" defined as completing the first twelve weeks of the study on the assigned medication and having a 50% or greater reduction in moderate severe headache days during weeks 9-12 post-randomization compared to the four weeks pre-randomization.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Atogepant 60 mg	Atogepant at a dose up to 60 mg daily.
DRUG	Propranolol 160 mg	Daily propranolol up to 80 mg twice daily.
DRUG	Topiramate 100 mg	Daily topiramate, up to 50 mg twice daily

Timeline

• Start date: 2025-07-09
• Primary completion: 2029-03-01
• Completion: 2029-12-01
• First posted: 2025-05-14
• Last updated: 2026-04-03

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study