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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Partial Onset Seizures
Interventions
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.

Trial Locations (25)

460-0004

Novartis Investigative Site, Nagoya

474-0031

Novartis Investigative Site, Ohbu

790-8524

Novartis Investigative Site, Matsuyama

814-0180

Novartis Investigative Site, Fukuoka

502-8558

Novartis Investigative Site, Gifu

041-1111

Novartis Investigative Site, Kameda-gun

060-8648

Novartis Investigative Site, Sapporo

670-8540

Novartis Investigative Site, Himeji

658-0032

Novartis Investigative Site, Kobe

244-0842

Novartis Investigative Site, Yokohama

861-1196

Novartis Investigative Site, Kōshi

945-8585

Novartis Investigative Site, Kashiwazaki

950-2085

Novartis Investigative Site, Niigata

879-5593

Novartis Investigative Site, Yufu

710-8522

Novartis Investigative Site, Kurashiki

700-8558

Novartis Investigative Site, Okayama

572-0085

Novartis Investigative Site, Neyagawa

355-0008

Novartis Investigative Site, Higashimatsuyama-shi

339-8551

Novartis Investigative Site, Saitama

524-0022

Novartis Investigative Site, Moriyama-shi

420-8688

Novartis Investigative Site, Shizuoka

329-0498

Novartis Investigative Site, Shimotsuke

113-8431

Novartis Investigative Site, Bunkyo-ku

990-0876

Novartis Investigative Site, Yamagata

409-3898

Novartis Investigative Site, Chūō

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY