NCT05724771 · ClinicalTrials.gov record · last posted 2024-08-20
COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study
Study acronym: COACT
StatusActive, Not Recruiting
PhasePhase 4
Started2023-01-26
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Record status
This record was last updated August 20, 2024 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.
Amendment record
2 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 2 times since 2023-02-02; most recent amendment 2024-08-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2024-08-19
Status change Recruiting→Active, Not Recruitingv2
| NCT Number |
NCT05724771 |
| Lead Sponsor |
Chicago Headache Center & Research Institute
|
| Conditions |
Chronic Migraine, Headache |
| Enrollment |
50 participants |
| Start Date |
2023-01-26 |
| Primary Completion |
2025-03 (estimated) |
| Study Completion |
2025-05 (estimated) |
| Updated on ClinicalTrials.gov |
2024-08-20 |