Epilepsies, Partial Clinical Trial
Official title:
Multiple Dose, Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of OXC XR as Adjunctive Therapy in Pediatric Subjects With Refractory Partial Epilepsy
Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive therapy in pediatric subjects with refractory partial epilepsy.
This was an open-label, multiple dose, multicenter study consisting of a Screening Period (up to 14 days), a Dosing Period (7 days), and a Follow-up Period (7 days). In-clinic visits occurred at screening, Visit 1 (Day 0), and Visit 2 (Day 7)/Early Discontinuation. All subjects received open-label SPN 804O as adjunctive therapy during the Dosing Period. At Visit 1, eligible subjects were assigned to 1 of 4 treatment groups (150, 300, 450, or 600mg/day) based on weight (15-<30, 30-<45, 45-<60, >=60kg). The Dosing Period consisted of six consecutive days of a daily dose, taken at home, followed by a final day with the dose taken on-site and including blood draws for PK analysis. ;
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