NCT01051193

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

A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Nobelpharma · Industry
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	Oxcarbazepine

Timeline

• Start date: 2010-01-05
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2010-01-18
• Last updated: 2019-11-15

Locations

24 sites across 1 country: Japan