COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy. The addition of a CGRPmAb could help in decreasing or eliminating these episodes, but this combination is considered "experimental" by many payers, which often leads to a denial of coverage. Currently, there is no reference in the literature or data to support the treatment of chronic migraine with OnabotulinumtoxinA and CGRPmAbs (Aimovig, Ajovy, Emgality or Vyepti) combination therapy. This has resulted in many patients and providers having to settle for one or the other. Investigators hopes to provide crucial data and findings to support the addition of CGRPmAb in some chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chicago Headache Center & Research Institute

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.