The results of the study of PER efficacy and safety in 52 patients with refractory focal epilepsy are presented. Mean age was 28.9 ± 14.0 years; proportion of male patients was 56%, duration of the disease over 10 years - 69.2%, symptomatic epilepsy - 76.9%, with frontal - 46.2% and temporal - 44.2% localization of epileptic lesion. Majority of patients - 71.2% started PER treatment after 3 preceding lines of therapy
The baseline seizure frequency of all types was 127.3 ± 82.3 per month; secondary generalized seizures - 6.7 ± 1.9 per month. After PER was added, a significant decrease in seizure frequency was observedalready during the first month, to 52.1 ± 29.3 seizures per month (Sign test, p = 0.00001) for seizures of all types and to 3.7 ± 1.7 (Sign test, p = 0.00001) for secondary generalized seizures. In an overwhelming majority of cases, duration of PER treatment was more than 6 months. In 58% of patients, seizure frequency decreased by more than 50% (responders). Seizure-free status for all seizure types was observed in 9% of cases at 12 month, and absence of secondary generalized seizures only was achieved in 31% of patients. Adverse events were observed in 30.1% of patients: aggression – 11.5% and drowsiness – 9.6%, with all other AEs observed more rarely. PER dose was reduced due to side effects in 7 patients (13.5%), and in 4 patients (7.7%) PER was discontinued. Average PER dose in adult patients was as low as 6 mg.
PER was effective in the treatment of refractory forms of focal epilepsy, reducing seizure frequency on average by 76% by the second month of treatment. In addition to a good clinical effect, PER demonstrated a rather acceptable and predictable safety profile.