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NCT05724771 · ClinicalTrials.gov registry record · Phase 4
COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study
A Phase 4 study of Chronic Migraine, Headache, sponsored by Chicago Headache Center & Research Institute.
- Active
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05724771: Active Phase 4 study of Chronic Migraine, Headache, sponsored by Chicago Headache Center & Research Institute.
NCT05724771 is a Phase 4 study of Chronic Migraine, Headache that is active but no longer recruiting, run by Chicago Headache Center & Research Institute. The registered enrollment target is 50 participants, below the 245-participant average among 4 other Chronic Migraine, Headache trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05724771, a Phase 4 study of Chronic Migraine, Headache, is active but no longer recruiting, sponsored by Chicago Headache Center & Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL)
Study Locations (1)
Illinois
- Chicago Headache Center & Research Institute - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2025-05 |
| Phase | Phase 4 |
What the registry record for NCT05724771 still lists
NCT05724771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 245-participant average among 4 other Chronic Migraine, Headache trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Chronic Migraine, Headache appearing as the primary indexed condition, and to 1 intervention - of which Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL) is the first listed.
NCT05724771 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05724771 about?
NCT05724771 is a clinical study titled "COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study". 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, whi...
What is the current status of trial NCT05724771?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-01-26. Estimated completion is 2025-05.
What conditions does trial NCT05724771 study?
This clinical trial studies the following conditions: Chronic Migraine, Headache.
What interventions are being tested in trial NCT05724771?
The interventions under investigation include: Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL) (DRUG).
Who is sponsoring clinical trial NCT05724771?
This trial is sponsored by Chicago Headache Center & Research Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05724771 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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