Your session is about to expire
← Back to Search
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
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 belowSelect...
My headaches have significantly improved with OnabotulinumtoxinA treatment.
Select...
I have had an average of 8 or more migraine days per month over the last 3 months.
Select...
I have had migraines for over a year.
Select...
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:Select...
I use gepants more than 5 days a month for sudden pain relief.
Select...
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
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination of Botox + CGRPmAbExperimental Treatment1 Intervention
OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50
Find a Location
Who is running the clinical trial?
Chicago Headache Center & Research InstituteLead Sponsor
1 Previous Clinical Trials
164 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am pregnant, planning to become pregnant, or currently breastfeeding.You currently use illegal drugs, or have a history of drug or alcohol abuse within the past year.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 used a CGRP inhibitor medication in the last 3 months.I haven't used gepants for prevention in the last week.I am between 18 and 75 years old with chronic migraines.I have had migraines for over a year.I have had at least 2 consecutive Botox treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Combination of Botox + CGRPmAb
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger