NCT06972056 Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
| NCT ID | NCT06972056 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,335 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,335 participants in total. It began in 2025-07-09 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Todd J Schwedt, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06972056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06972056 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06972056 currently recruiting?
Yes, NCT06972056 is actively recruiting participants. Contact the research team at ARZAPTTrial@mayo.edu for enrollment information.
Where is the NCT06972056 trial being conducted?
This trial is being conducted at Hazel Green, United States, Flagstaff, United States, Phoenix, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06972056 clinical trial?
NCT06972056 is sponsored by Mayo Clinic. The principal investigator is Todd J Schwedt, M.D. at Mayo Clinic. The trial plans to enroll 1,335 participants.
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