COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study
Unknown statusPhase 4NCT05724771
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Assessing the Safety and Efficacy of Utilizing CGRPmAb Fremanezumab (Ajovy) in Chronic Migraine Patients Currently on Monotherapy OnabotulinumtoxinA (Botox).
- Conditions
- Interventions
- Drug: Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL)
- Sponsor
- Chicago Headache Center & Research Institute
- Start date
- 2023-01-26
- Primary completion
- 2025-03
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05724771