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Procedure

Botox + Fremanezumab for Chronic Migraine (COACT Trial)

Phase 4

Waitlist Available

Research Sponsored by Chicago Headache Center & Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Achieved a clinically appropriate response from monotherapy OnabotulinumtoxinA at enrollment (visit 2): ≥50% reduction in mean monthly headache days of at least moderate severity OR Reduction of ≥7 mean monthly headache days of at least moderate severity OR HIT-6 reduction of ≥5 points

History of ≥8 monthly migraine days (average from 3 previous months prior to enrollment (visit 2))

Must not have

Utilizing gepants as an acute rescue treatment >5 days per month

Female is pregnant, planning to become pregnant during the course of the study, or currently lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial seeks to prove the combo of OnabotulinumtoxinA and CGRPmAbs is effective for chronic migraine, which may help patients get better coverage.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site, allergic responses, muscle weakness near where the drug was injected, neck pain or stiffness due to Botox; Fremanezumab may cause injection site reactions as well as potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My headaches have significantly improved with OnabotulinumtoxinA treatment.

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

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I have had migraines for over a year.

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I have had at least 2 consecutive Botox treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am pregnant, planning to become pregnant, or currently breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of monthly migraine days with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

Secondary study objectives

To assess improvements in HIT-6 (Headache Impact Test) score of >5 point reduction with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.