COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study (COACT)
Chronic Migraine, Headache
About this trial
This is an interventional treatment trial for Chronic Migraine, Headache
Eligibility Criteria
Inclusion Criteria: Chronic migraine patients between 18 to 75 years old Chronic migraine patients with ≥ 12-month history of migraine Participant has received at least 2 consecutive OnabotulinumtoxinA treatment at screening (visit 1) 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)) Exclusion Criteria: History of <8 monthly migraine days (average from 3 previous months prior to enrollment (visit 2)) Patients with current use, or use within 3 months prior to screening (visit 1) a CGRPmAbs (Aimovig, Ajovy, Emgality, or Vyepti) Concomitant use of gepants as a preventative treatment < 1 week prior to screening (visit 1). Utilizing gepants as an acute rescue treatment >5 days per month. Current user of recreational or illicit drugs, or a history within 1 year prior to screening (visit 1) of drug or alcohol abuse or dependence Clinically significant hematologic, endocrine, cardiovascular, pulmonary, gastrointestinal, or neurologic disease. If there is a history of such a disease, but the condition has been stable for more than 1 year prior to screening (visit 1) and is judged by the PI as not likely to interfere with participation in the study, the participant may be included. Female is pregnant, planning to become pregnant during the course of the study, or currently lactating.
Sites / Locations
- Chicago Headache Center & Research InstituteRecruiting
Arms of the Study
Arm 1
Experimental
Combination of Botox + CGRPmAb
OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50