Experience of Relatox (botulinum toxin type A) using for chronic migraine treatment

Objective. The aim of the study was to investigate the efficacy, safety, and clinical features of the use of botulinum toxin type A injections (Relatox, JSC NPO Mikrogen, Russian Federation) for the treatment of chronic migraine in the routine practice of a specialized headache center. Material and methods. The open-label, retrospective, non-comparative study included 150 patients with a mean age of 39.0±12.9 years. Forty percent of patients were non-responders to two or more classes of migraine prophylaxis medications. Relatox was administered at doses of 155—195 U according to the PREEMPT (75.3%, n=113) or «Follow the Pain» (24.7%, n=37) protocols every 12 weeks. Results. Before treatment, the average number of days with migraine in the study group was 24.4±5.7, whereas after 12 weeks the number of days with migraine became 14.3±9.5 (p<0.001). The proportion of patients with ≥30% reduction in days with migraine after 12 weeks of therapy was 61.3% (n=92), with ≥50% reduction — 48.0% (n=72), with ≥75% reduction — 20.7% (n=31). Adverse events were reported in 3.3% (n=5): chewing difficulties (n=2), mild ptosis (n=1), neck muscle weakness (n=1), and flu-like symptoms (n=1). Conclusion. A real-world clinical trial confirmed the efficacy and safety of Relatox for the treatment of chronic migraine. The cumulative effect of Relatox was noted: an increase in effectiveness while following the protocol of administration once every 12 weeks.