NCT00918047

Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive therapy in pediatric subjects with refractory partial epilepsy.

Detailed description

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.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	SPN-804O	Open Label study

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-11-01
• First posted: 2009-06-11
• Last updated: 2017-07-02

Locations

8 sites across 1 country: United States