Vigabatrin pediatric dosing information for refractory complex partial seizures: Results from a population dose–response analysis

Summary We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures (r CPS ) that would produce efficacy comparable to that observed for approved adult dosages. A dose–response model related seizure‐count data to vigabatrin dosage to identify dosages for pediatric r CPS patients. Seizure‐count data were obtained from three pediatric and two adult r CPS clinical trials. Dosages were predicted for oral solution and tablet formulations. Predicted oral solution dosages to achieve efficacy comparable to that of a 1 g/day adult dosage were 350 and 450 mg/day for patients with body weight ranges 10–15 and >15–20 kg, respectively. Predicted oral solution dosages for efficacy comparable to a 3 g/day adult dosage were 1,050 and 1,300 mg/day for weight ranges 10–15 and >15–20 kg, respectively. Predicted tablet dosage for efficacy comparable to a 1 g/day adult dosage was 500 mg/day for weight ranges 25–60 kg. Predicted tablet dosage for efficacy comparable to a 3 g/day adult dosage was 2,000 mg for weight ranges 25–60 kg. Vigabatrin dosages were identified for pediatric r CPS patients with body weights ≥10 kg.