A long-term open multicenter trial was carried out in 15 European centers with therapy-resistant epileptics to evaluate the efficacy and safety of progabide, a new antiepileptic GABA receptor agonist; 187 patients, suffering from partial epilepsy (57), primary generalized epilepsy (20), secondary generalized epilepsy (21 ), and unclassified generalized epilepsy (2 ), participated in the study. All patients had a total seizure frequency higher than one per month in spite of standard antiepileptic medication; 46 had a mean partial seizure frequency from daily to weekly. Progabide was administered at a mean daily dose of 30.5 mg/kg/day as an add-on to the standard antiepileptic drugs up to one year in 115 patients; 37 patients (19.8) dropped out because of reasons which were not drug-related (bad compliance, lost to follow-up); in 12 patients (6.5) progabide was withdrawn for side effects and in 20 (10.7) for lack of efficacy. 71.3 of patients treated for one year (62 considering the ‘cumulative’ number of patients) experienced more than a 50 reduction in seizure frequency. This reduction was equally present in patients with partial epilepsy (63.9) and with generalized epilepsy (62.2 of patients with primary and 57.1 with secondary generalized epilepsy). No signs of tolerance phenomena to the antiepileptic effect of progabide were observed. No side effects were reported in 56.7 of the patients. Clinical side effects were mild and transient, leading to progabide discontinuation in 6.5 of the patients only; an increase in SGPT was observed in 5.7 of the patients, these increases were transient and without any clinical symptom. The results of this long-term study confirm the results from several open and controlled trials and show that progabide is a valuable antiepileptic also in long-term ther
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