Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
ConditionMigraine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Atogepant 60 mg
DrugAtogepant at a dose up to 60 mg daily.
Propranolol 160 mg
DrugDaily propranolol up to 80 mg twice daily.
Topiramate 100 mg
DrugDaily topiramate, up to 50 mg twice daily
Treatment groups
1,335 Participants
are divided into 3 treatment groupsGroup A: AtogepantActive comparator 1 intervention
Group B: PropranololActive comparator 1 intervention
Group C: TopiramateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as: 1. Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND 2. Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
Time frame
Weeks 9-12 post-randomization compared to the 4 weeks prior to randomizationSecondary outcomes
1
Migraine Specific Quality-of-Life - Role Function-Restrictive
The role function-restrictive domain of the Migraine Specific Quality of Life questionnaire is a 7-item valid measure of functional impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness during the past four weeks.
Time frame
Week 12 post-randomization vs. baseline2
Treatment Responder (propranolol vs. topiramate)
This study will use a "treatment responder" primary endpoint that will investigate medication superiority using a combination of headache frequency reduction and medication persistence. To achieve this, a binary endpoint of treatment response will be used that combines effectiveness and medication persistence at the individual level, with success defined as: 1. Completing the first 12 weeks of the study on the assigned medication without discontinuation due to any reason, AND 2. Having a 50% or greater reduction in moderate to severe headache days during weeks 9-12 compared to a 4-week pre-randomization period.
Time frame
Weeks 9-12 post-randomization vs. the 4 weeks prior to randomization3
Headache Impact Test-6 (HIT-6)
The HIT-6 is a six-item questionnaire that measures the impact headaches have on a person's ability to function on the job, at home, at school, and in social situations.
Time frame
week 12 post-randomization vs. baseline4
Medication-Related Adverse Events
This medication-related adverse event outcome will consist of all adverse events that are deemed to be at least possibly related to the study medication.
Time frame
All 12 weeks of the randomized treatment phaseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
University of Iowa
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
AbbVie
Collaborator
Source ClinicalTrials.gov