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Two-Year Study of Botox Injection for Migraine Provides Long-Term Use Data

Prolonged use of botox treatment in chronic headache sufferers shown safe

A PPM Brief

A multicenter, open-label prospective study (The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label, or COMPEL, study) published in the Journal of Headache and Pain1 provided more clinical data on the risk-benefit profile of onabotulinumtoxinA (botox) injections, a treatment approved for the prevention of headache in those with chronic migraine, beyond one year.

In the study, adults age 18 to 73 with chronic migraine received 155 units of onabotulinumtoxinA over 31 sites in a fixed-site, fixed-dose paradigm across seven head and neck muscles. The units were delivered every 12 weeks (± 7 days) over nine treatment cycles, or 108 weeks. Just over 700 patients enrolled, with 52.1% (n = 373) completing the study and the majority of patients (84.8%) being female. At 24 weeks, investigators allowed for the addition or change of oral preventive treatment, which occurred in 6.1% of participants.1

Researchers assessed the safety and tolerability of the injections by reviewing the frequency and nature of adverse events; subgroup analyses looked at patients with or without concomitant oral preventive treatment and acute medication overuse before the study. Adverse events were determined specifically at each visit through patient self-report, general non-directed and directed questioning, and physical examination. Approximately 130 patients (18.3%) reported at least one treatment-emergent adverse event, most frequently reported as neck pain (4.1%). While one patient reported a serious treatment-related adverse event (rash), no deaths or other serious injuries were reported.1

Before the study, patients reported an average of 22 headache days per month. By 60 and 108 weeks, a significant reduction in headache days (minus 9.2 days and minus 10.7 days, respectively, p < 0.0001) was observed.1

Due to the nature of the study looking at data over the course of more than one year, the primary outcome was the number of headache day reductions at 108 weeks, while the secondary outcome targeted 60-week reductions. A change in the 6-item Headache Impact Test (HIT-6) score (minus 7.1 point change at week 108) accompanying the study was also reported.1

“The COMPEL Study provides additional clinical evidence for the consistency of the efficacy and the long-term safety and tolerability of onabotulinumtoxinA for the prevention of headache in those with CM,” the study authors concluded.

Last updated on: March 14, 2018
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