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ACTIVE NOT RECRUITING
NCT05724771
PHASE4

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

Sponsor: Chicago Headache Center & Research Institute

View on ClinicalTrials.gov

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.

Official title: Assessing the Safety and Efficacy of Utilizing CGRPmAb Fremanezumab (Ajovy) in Chronic Migraine Patients Currently on Monotherapy OnabotulinumtoxinA (Botox).

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-01-26

Completion Date

2025-05

Last Updated

2024-08-20

Healthy Volunteers

No

Interventions

DRUG

Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL)

OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL

Locations (1)

Chicago Headache Center & Research Institute

Chicago, Illinois, United States