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A phase IIIb, randomized, one-blind, multicenter, active-controlled, parallel-group trial was conducted to compare the safety and effectiveness of Relatox (the first Russian botulinum toxin type A) and Botox (onabotulinumtoxinA) for preventing headaches in adults battling chronic migraine.
Relatox is an effective prophylactic treatment for chronic migraine in adult patients as it shows non-inferior efficacy and safety to Botox.
A phase IIIb, randomized, one-blind, multicenter, active-controlled, parallel-group trial was conducted to compare the safety and effectiveness of Relatox (the first Russian botulinum toxin type A) and Botox (onabotulinumtoxinA) for preventing headaches in adults battling chronic migraine.
Overall, 209 participants, ranging in age from 19 to 65 years, and suffering from chronic migraine, were enrolled in the trial. These individuals were divided into two groups: one receiving injections of the Russian botulinum toxin type A, referred to as Relatox (n=101), and the other receiving injections of onabotulinumtoxinA, commonly known as Botox (n=108).
The study lasted for a duration of 16 weeks and encompassed a total of five patient visits scheduled at four-week intervals. Both Relatox and Botox were administered once across seven muscle groups located in the neck and head, with a dosage ranging from 155 to 195 units. The main measure of effectiveness was the mean change in the number of days with headaches compared to the beginning of the study, assessed at the 12-week mark.
Additional effectiveness measures included the mean changes from the study's start to the 12-week point in the number of days with migraines, days requiring acute headache pain medication, headache intensity levels, the percentage of subjects achieving a decline of at least 50% in headache days compared to the study's start, the percentage of volunteers exhibiting medication overuse, and the percentage of individuals with a severe (score of ≥60) Headache Impact Test-6 (HIT-6) score, as well as those with a severe (score of ≥21) Migraine Disability Assessment Scale (MIDAS) score.
The analysis revealed a substantial average reduction in the frequency of headache days from the study's starting point. There were no clinically meaningful variations between the Relatox and Botox groups at week 12 (-10.89 vs. -10.06), as well as at other assessment points. Additionally, notable improvements from the baseline were noted for all secondary measures of effectiveness across all time points, with no discernible discrepancies between both groups.
In the group receiving Relatox, 75.0% of patients achieved a reduction of at least 50% in headache days from the study's outset, while the proportion was 70% in the Botox group (with an odds ratio of 1.58). Adverse events were reported by 15.8% of subjects in the Relatox group and 15.7% in the Botox group. There were no unforeseen adverse events detected.
Relatox was efficacious as a preventive therapy for chronic migraine among adult patients. It resulted in noteworthy enhancements from the baseline across various evaluations of headache symptoms, disability associated with headaches, and overall quality of life. A novel aspect of this study was the side-by-side comparison of two botulinum toxin type A products within parallel groups. Relatox exhibited non-inferior safety and effectiveness to Botox to relieve chronic migraine.
Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova
[Botulinum toxin type A (Relatox) in the treatment of chronic migraine in adults: results of phase IIIb, randomized, one-blind, multicenter, active-controlled, parallel-group trial]
A R Artemenko et al.
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