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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares three medicines to prevent migraines: atogepant, topiramate, and propranolol. It will test which works better and causes fewer problems in adults ages 18–70 with migraines. Participants are assigned a medicine by chance and track their headaches in a daily diary and at study visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–70 years old.
  • You have a migraine diagnosis, with or without aura (changes in sight or other senses), or chronic migraines. Daily or nonstop headaches are allowed.
  • Your migraines began before age 50 and have lasted at least 12 months.
  • You have at least 4 moderate to severe headache days a month, confirmed with a 4-week diary. A day counts if the headache lasts at least 4 hours or you take a migraine-specific medicine to treat it.
  • If you already use a migraine prevention treatment, you agree to keep the same dose for the first 16 weeks.
  • You are not pregnant or breastfeeding. Women who can become pregnant must agree to use effective birth control.
  • You can and agree to give informed consent, meaning you understand the study and agree to join.
  • You can and agree to complete all study visits.

Who can't join

  • You cannot safely take, or are unwilling to take, any of the three study medicines.
  • You currently take or previously took atogepant, propranolol, or topiramate. Occasional propranolol use as needed, such as for anxiety, is allowed.
  • You currently use a CGRP-targeting migraine prevention medicine or a beta-blocker, a type of medicine often used for blood pressure.
  • You have brainstem aura (symptoms linked to the base of the brain), hemiplegic migraine (with muscle weakness), retinal migraine (vision changes in one eye), only aura without headache, or migraines only during menstrual periods.
  • You have trigeminal autonomic cephalalgias (headaches with symptoms such as eye watering), facial nerve pain, or headaches caused by another condition. Headaches from overusing medicine are allowed.
  • You started a migraine prevention treatment or changed its dose within the past 12 weeks.
  • You used opioids or butalbital on an average of 5 or more days a month for at least the past 3 months.
  • You have or have had epilepsy (a seizure disorder), have severe liver problems, or have moderate or worse kidney problems.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (37)

AL

AZ

CA

CO

FL

KS

MA

MN

MO

NC

NE

NJ

NV

NY

OH

OR

PA

RI

TN

TX

UT

WI

WV