Botox + Fremanezumab for Chronic Migraine
(COACT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Chicago Headache Center & Research Institute

No Placebo Group

Prior Safety Data

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

My headaches have significantly improved with OnabotulinumtoxinA treatment.

I have had an average of 8 or more migraine days per month over the last 3 months.

I am between 18 and 75 years old with chronic migraines.

+2 more

Exclusion Criteria

My serious health conditions have been stable for over a year and won't affect my study participation.

I've had fewer than 8 migraines a month on average in the last 3 months.

I use gepants more than 5 days a month for sudden pain relief.

+4 more

Participant Groups

The study tests whether adding Fremanezumab (a CGRPmAb) to Botox treatment helps reduce breakthrough headaches in chronic migraine sufferers. This combination therapy is experimental and aims to provide data supporting its effectiveness where current literature lacks.

1Treatment groups

Experimental Treatment

Group I: Combination of Botox + CGRPmAbExperimental Treatment1 Intervention

OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50