Botox + Fremanezumab for Chronic Migraine
(COACT Trial)
Trial Summary
What is the purpose of this trial?
Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy. The addition of a CGRPmAb could help in decreasing or eliminating these episodes, but this combination is considered "experimental" by many payers, which often leads to a denial of coverage. Currently, there is no reference in the literature or data to support the treatment of chronic migraine with OnabotulinumtoxinA and CGRPmAbs (Aimovig, Ajovy, Emgality or Vyepti) combination therapy. This has resulted in many patients and providers having to settle for one or the other. Investigators hopes to provide crucial data and findings to support the addition of CGRPmAb in some chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
Eligibility Criteria
This trial is for chronic migraine patients aged 18-75 who've had migraines for over a year and have seen some improvement with Botox alone. They must not be pregnant, planning pregnancy, or nursing, and should not have significant other diseases that could affect the study. Patients can't join if they've used certain migraine drugs recently or have a recent history of substance abuse.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
OnabotulinumtoxinA Treatment
Participants receive OnabotulinumtoxinA treatment at Day 1 and Day 90
CGRPmAb Fremanezumab Treatment
Participants initiate CGRPmAb Fremanezumab treatment with monthly doses for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CGRPmAb (Fremanezumab)
- OnabotulinumtoxinA (Botox)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chicago Headache Center & Research Institute
Lead Sponsor