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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with chronic migraines who continue to experience headaches after Botox treatment. Researchers are testing whether adding fremanezumab, a CGRP monoclonal antibody that blocks a protein linked to migraines, can reduce these headaches. This study targets individuals who have experienced migraines for at least a year, have at least eight migraine days per month, and have seen some improvement with Botox alone. The goal is to determine if this combination offers better relief than Botox alone. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot use certain migraine treatments like CGRPmAbs or gepants close to the trial start. It's best to discuss your specific medications with the trial team.

What is the safety track record for the treatments in this trial?

Research has shown that Botox is safe and effective for preventing chronic migraines. Studies have found that combining Botox with Fremanezumab, a medication that blocks a protein linked to migraines, is also safe and effective.

In everyday use, individuals taking this combination have experienced fewer migraines without major side effects. Reports indicate that using these treatments together is safe, with no serious problems reported by users.

Overall, the evidence is promising for those considering this treatment for chronic migraines. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Botox and Fremanezumab for treating chronic migraines because it merges two powerful approaches. Current treatments often involve Botox alone or CGRP inhibitors like Fremanezumab separately. This new combination targets migraines by both relaxing muscles with Botox and blocking migraine-related proteins with Fremanezumab. By tackling the problem from two angles, it may offer more comprehensive relief for patients who haven't found success with traditional treatments.

What evidence suggests that this trial's treatments could be effective for chronic migraine?

Research has shown that using Botox with Fremanezumab, a medication targeting migraines, may reduce chronic migraines. This trial will evaluate the combination of Botox and Fremanezumab. Studies have found that this combination can decrease the number of migraine days and lessen pain. In everyday use, patients using both treatments together have experienced fewer severe headaches, especially as their Botox treatment nears its end. This combination has generally been well-tolerated, with no new safety issues. Although insurance companies might consider this combination experimental, early research supports its potential benefits for people with chronic migraines. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. journals.sagepub.com journals.sagepub.com/doi/10.1177/25158163241238448

Real-world effectiveness of add-on fremanezumab in ... Several outpatient retrospective studies reported good results with various oral preventives in combinations, although a placebo-controlled ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8586140/

Real-World Evidence for Control of Chronic Migraine Patients ... In this real-world study, combination treatment with onabotulinumtoxinA and CGRP mAbs was well tolerated, with no new safety signals identified.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05724771

NCT05724771 | COACT Study: CGRPmAbs + ... Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy.

4. jdc.jefferson.edu jdc.jefferson.edu/context/headache/article/1020/viewcontent/real_world_effectiveness_of_add_on_fremanezumab_in_patients_receiving_onabotulinumtoxina_for_the_prevention_of_chronic_migraine.pdf

Real-World Effectiveness of Add-Onfremanezumab in Patients ... Conclusion: Concomitant fremanezumab and onabotA for CM prevention were effective at reducing the number of MHD and lessening PI, particularly ...

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01721-6

Real-world effectiveness of Anti-CGRP monoclonal antibodies ... Real-world effectiveness of Anti-CGRP monoclonal antibodies compared to OnabotulinumtoxinA (RAMO) in chronic migraine: a retrospective, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9300070/

Combination CGRP monoclonal antibody and ... OnabotulinumtoxinA, an approved preventive chronic migraine (CM) treatment, is well tolerated with demonstrated efficacy across multiple clinical trials. When ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10751376/

Combination of anti-CGRP/CGRP-R mAbs with ... OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.788159/full

Real-World Evidence for the Safety and Efficacy of CGRP ... The position statement reports that combination treatment with onabotulinumtoxinA and a CGRP mAb is probably effective, and CGRP therapy may be ...

9. ajmc.com ajmc.com/view/real-world-data-highlight-efficacy-saftey-of-combination-treatment-for-chronic-migraine

Real-World Data Highlight Efficacy, Safety of Combination ... A combination of onabotulinumtoxinA and a calcitonin gene-related peptide monoclonal antibody appears effective and safe in patients with chronic migraine.