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Botox + Fremanezumab for Chronic Migraine (COACT Trial)
Phase 4
Recruiting
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))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
COACT Trial 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.Check my eligibility
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.See study design
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.
COACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I have had migraines for over a year.
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I have had at least 2 consecutive Botox treatments.
COACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in number of monthly migraine days with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
Secondary outcome measures
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.
COACT Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination of Botox + CGRPmAbExperimental Treatment1 Intervention
OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to join this clinical trial?
"A prerequisite for enrolment in this medical trial is chronic migraine and a patient's age must fall between 18 - 75. This research program has an allocated recruitment quota of 50 participants."
Answered by AI
Is enrollment into this experiment available at the present time?
"As indicated by the clinicaltrials.gov portal, this medical trial is recruiting participants at present. The post was issued on January 26th 2023 and recently modified on February 2nd of the same year."
Answered by AI
Does this study accept participants aged 55 and older?
"To be eligible for this trial, potential participants must range from 18 to 75 years old. Seperate trials exist for those under 18 (42 studies) and over 65 (177 studies)."
Answered by AI
What risks and benefits come with the Combination of Botox + CGRPmAb treatment?
"This combination of Botox and CGRPmAb has been given a score of 3, as it is currently in Phase 4 trials - meaning approval has already been granted."
Answered by AI
How many individuals are being enrolled in this inquiry?
"Affirmative. According to clinicaltrials.gov, this medical trial is presently in search of participants and was introduced on January 26th 2023 with a recent update occurring February 2nd 2023. It needs 50 patients from one location to complete the study."
Answered by AI
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