drugset / Trial / NCT01051193

Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

NCT01051193

Phase 2/3 Completed 88 enrolled Nobelpharma
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.

Timeline

Start
2010-01-05
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxcarbazepine Small molecule

Indications