A Phase 4 interventional study of Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL) in Chronic Migraine, Headache, sponsored by Chicago Headache Center & Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Chicago Headache Center & Research Institute · Phase 4, Interventional, and Treatment
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 IV prospective open label interventional clinical study evaluating beneficial outcomes of the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
The investigators will enroll patients with ≥2 OnabotulinumtoxinA treatments at screening with a history of ≥8 monthly migraine days (average from 3 previous months prior to enrollment (visit 2)). Between visit 1 (screening) and visit 3, all patients will be on monotherapy OnabotulinumtoxinA for up to 12 weeks.
Patients will be administered a total of 2 OnabotulinumtoxinA treatments for the duration of the entire study. OnabotulinumtoxinA treatment will be administered at Day 1 (visit 2) and Day 90 (visit 4), with a treatment window ±6 days.
OnabotulinumtoxinA treatment of 155 units or 195 units will be injected intramuscularly over 31-35 injections of head and neck muscles. Study patients must be on a stable OnabotulinumtoxinA dose at screening (visit 1), that dose will be used for the duration of the study.
Dosing paradigm:
At Day 7 (visit 3) study patients will initiate CGRPmAbs treatment of Fremanezumab 225mg/1.5mL monthly dose for 6 months. Doses will be taken on Days: 7, 37, 67, 97, 127, and 157; with a treatment window ±2 days.
Acute rescue utilizing -gepants will be limited to no more than 5 days per month.
No use of -gepants as a preventative treatment for at least 1 week prior to screening (visit 1) and throughout the duration of the study.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Chicago Headache Center & Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Achieved a clinically appropriate response from monotherapy OnabotulinumtoxinA at enrollment (visit 2):
Exclusion Criteria:
OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL = 50
Drug: Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL)
OnabotulinumtoxinA + Fremanezumab 225mg/1.5mL
Change in number of monthly migraine days with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
Change in number of monthly migraine days from baseline.
Time frame: 6 months
To assess improvements in HIT-6 (Headache Impact Test) score of >5 point reduction with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
Change in HIT-6 (Headache Impact Test) assessment score from baseline.
Time frame: 6 months
Plan to share: Undecided
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Chicago Headache Center & Research Institute