Abstracts

Rationale: We describe the electroclinical evolution of adjuvant treatment with perampanel (PER) in patients with primary generalized epilepsy at 12 months, evaluating their response both at clinical level and their generalized epileptiform activity of the electroencephalogram (EEG). Methods: This is a unicentric, observational, open and non-interventional study. For the EEG analysis, there were analyzed the number and duration of the generalized discharges in the EEG registry performed for 45 minutes at the same time of day and under patient's conditions.  Results: The sample included 38 patients (22 men), all of them with primary generalized epilepsy: 21 patients with idiopathic generalized epilepsy and 17 with juvenile myoclonic epilepsy. Before PER treatment, the mean total generalized seizures in the previous 3 months was 26.8 seizures: 10 patients with absences; 11 patients with myoclonus and 17 patients presented tonic-clonic seizures. The most common concomitant antiepileptic drug (AED) was Levetiracetam (LEV) in 24 patients, with an average dose of 1800 mg / day. Before treatment with PER, 8 patients had a normal EEG, 22 patients had an EEG with generalized activity, 1 patient with focal activity and 7 patients with focal and generalized activity. At 6-month follow-up, data from 34 patients (89.4% of the patients in the sample) could be analyzed. The mean dose of PER was 4.6 mg / day and the titration schedule was 2 mg every two weeks in 97% of patients. At 6 months of adjuvant treatment with PER, 70.5% of patients (24 patients) were seizure free for all primary generalized seizures (p-value To date 26 patients have been followed for at least 12 months, with an average dose of PER of 5.15 mg / day. At 12 months, 22 of the 26 patients analyzed (85%) were seizure free for all primary generalized seizures (p-value < 0.00001). After 1 year of adjuvant treatment with PER, only 1 patient continues with absences, another patient with myoclonic seizures and 2 patients with tonic-clonic seizures. During the 12-month follow-up there were a total of 3 withdrawals due to adverse effects, most of which were seen within the first 3 months of treatment. 73.6% of patients described no adverse effects after 1 year of follow-up. The most common adverse effects were: irritability, drowsiness, fatigue and anxiety, most of which were classified as mild or moderate. EEG data after one year of adjuvant treatment with PER showed that the EEG remains unchanged in 10 patients, 4 patients improved their discharges by less than 50%, 6 improved more than 50% in their generalized discharges; 4 patients reported normalization of the EEG and 1 patient showed a worsening of his EEG. Conclusions: PER is shown as a safe and effective AED as adjuvant treatment for primary generalized epilepsy in clinical practice, being confirmed as a broad-spectrum AED. Funding: 1. French JA, et. al., Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy: A randomized trial. Neurology 2015 Sep 15; 85(11):950-7.2. V Villanueva et. al. Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: The FYDATA study. Epilepsy Research 126 (2016), 210-210.3. Montoya FJ. et. al., First real-life experience with PER in Primary generalized epilepsies. Abstract #2134. II Congress of the European Academy of Neurology, Copenhaguen, 2016. 4. Stefano Pro, Edoardo Vicenzini et. al. Effects of levetiracetam on generalized discharges monitored with ambulatory EEG in epileptic patients. Seizure 18 (2009) 133–138.