Adjunctive pregabalin therapy in mentally retarded, developmentally delayed patients with epilepsy.

This retrospective study evaluated the efficacy and tolerability of adjunctive pregabalin (PGB) therapy in mentally retarded, developmentally delayed patients. The primary efficacy measure was the change in the median frequency of seizure days per week between the baseline (8 weeks prior to initiating PGB) and treatment (12 weeks of titration and maintenance) periods. Inclusion criteria were: documented epilepsy treated with antiepileptic drug, at least one seizure during the baseline period, and lack of prior exposure to PGB. Seven patients (four female, three male, mean age=43) with multiple seizure types (generalized tonic-clonic, tonic, partial, and atypical absence) met the inclusion criteria. The mean dose of PGB was 293 mg/day (range=150-350 mg/day). PGB was efficacious, resulting in a significant reduction in the median frequency of seizure days/week between baseline and treatment (1.38 vs 0.50, P=0.018). The 50% responder rate was 71%. The adverse effects at last follow-up (mean 13 months) included weight gain, myoclonus, and sedation.