NCT00975715

Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Conditions

• Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	TRI476	TRI476 oral suspension doses, based on body weight twice daily
DRUG	Placebo to TRI476	Placebo oral suspension, taken twice daily
DRUG	Benzodiazepines	Benzodiazepines could be used as needed as rescue medication during the duration of the study.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-09-11
• Last updated: 2014-07-16
• Results posted: 2014-01-24

Locations

25 sites across 1 country: Japan