Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Conditions

• Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 9, 2025

Status verified

May 2026

Primary completion

Mar 1, 2029

Completion

Dec 1, 2029

Study Design

Enrollment

1,335 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 .

Primary Outcome Measure

Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol) [ Time Frame: Weeks 9-12 post-randomization compared to the 4 weeks prior to randomization ]

Central Contacts

• Michael R Leonard, MDiv
  480-342-2908
  [email protected]
• Dani C Smith, M.S.
  [email protected]

Locations (35)

Find similar trials in Flagstaff, AZ

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