Botox + Fremanezumab for Chronic Migraine

(COACT Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Chicago Headache Center & Research Institute

Must be taking: OnabotulinumtoxinA

Must not be taking: CGRPmAbs, Gepants

Disqualifiers: Drug abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

50 Participants Needed

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 have had migraines for over a year.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

OnabotulinumtoxinA Treatment

Participants receive OnabotulinumtoxinA treatment at Day 1 and Day 90

12 weeks

2 visits (in-person)

CGRPmAb Fremanezumab Treatment

Participants initiate CGRPmAb Fremanezumab treatment with monthly doses for 6 months

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CGRPmAb (Fremanezumab)
• OnabotulinumtoxinA (Botox)

Trial Overview 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.

Participant Groups

Group I: Combination of Botox + CGRPmAb Experimental Treatment 1 Intervention

OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50

Who Is Running the Clinical Trial?

Chicago Headache Center & Research Institute

Lead Sponsor

Trials

2

Recruited

210+