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

Condition(s) targeted: Partial Onset Seizures

Intervention: Oxcarbazepine (Drug); Placebo Comparator (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +81-3-3797-8031

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Primary outcome: Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period.

Secondary outcome:

Seizure Frequency of specific duration

Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency.

Percent changes in the seizure frequency by subtype

Clinical Global Impression of Change (CGIC)

Safety and tolerability(Adverse events, Laboratory tests, Vital signs, Electrocardiogram (ECG)

Minimum age: 4 Years. Maximum age: 14 Years. Gender(s): Both.

Criteria:

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.

Other protocol-defined inclusion/exclusion criteria may apply

Novartis Pharmaceuticals, Phone: +81-3-3797-8031

Novartis Investigational Site, Neyagawa, Japan; Recruiting

Novartis Investigative Site, Kobe, Japan; Recruiting

Novartis Investigative Site, Bunkyo, Japan; Recruiting

Novartis Investigative Site, Yokohama, Japan; Recruiting

Novartis Investigative Site, Okayama, Japan; Recruiting

Novartis Investigative Site, Fukuoka, Japan; Recruiting

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Starting date: August 2009
Last updated: September 10, 2009