COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study
- Conditions
- Chronic Migraine, Headache
- Registration Number
- NCT05724771
- Lead Sponsor
- Chicago Headache Center & Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Chronic migraine patients between 18 to 75 years old<br><br> - Chronic migraine patients with = 12-month history of migraine<br><br> - Participant has received at least 2 consecutive OnabotulinumtoxinA treatment at<br> screening (visit 1)<br><br> - Achieved a clinically appropriate response from monotherapy OnabotulinumtoxinA at<br> enrollment (visit 2):<br><br> - =50% reduction in mean monthly headache days of at least moderate severity OR<br> Reduction of =7 mean monthly headache days of at least moderate severity OR<br><br> - HIT-6 reduction of =5 points<br><br> - History of =8 monthly migraine days (average from 3 previous months prior to<br> enrollment (visit 2))<br><br>Exclusion Criteria:<br><br> - History of <8 monthly migraine days (average from 3 previous months prior to<br> enrollment (visit 2))<br><br> - Patients with current use, or use within 3 months prior to screening (visit 1) a<br> CGRPmAbs (Aimovig, Ajovy, Emgality, or Vyepti)<br><br> - Concomitant use of gepants as a preventative treatment < 1 week prior to screening<br> (visit 1).<br><br> - Utilizing gepants as an acute rescue treatment >5 days per month.<br><br> - Current user of recreational or illicit drugs, or a history within 1 year prior to<br> screening (visit 1) of drug or alcohol abuse or dependence<br><br> - Clinically significant hematologic, endocrine, cardiovascular, pulmonary,<br> gastrointestinal, or neurologic disease. If there is a history of such a disease,<br> but the condition has been stable for more than 1 year prior to screening (visit 1)<br> and is judged by the PI as not likely to interfere with participation in the study,<br> the participant may be included.<br><br> - Female is pregnant, planning to become pregnant during the course of the study, or<br> currently lactating.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in number of monthly migraine days with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
- Secondary Outcome Measures
Name Time Method 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.