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Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

NCT00975715•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
•A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).

Exclusion Criteria

•A document history of generalized status epileptics in the past 6 months.
•Seizures having a metabolic, neoplastic, or active infectious origin.

Locations (25)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Ohbu, Aichi-ken, Japan

Novartis Investigative Site

Matsuyama, Ehime, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Gifu, Gifu, Japan

Novartis Investigative Site

Kameda-gun, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Himeji, Hyōgo, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Key Dates

Start Date

September 1, 2009

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

July 16, 2014

Enrollment

ACTUAL participants

Conditions

Partial Onset Seizures

Interventions

TRI476

DRUG

Placebo to TRI476

DRUG

Benzodiazepines

DRUG

A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

NCT02072824

Partial Onset Seizures

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COMPLETEDPHASE3

A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

NCT01710657

EpilepsyPartial Onset Seizures

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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