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

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Partial Onset Seizures

Treatments: Drug: Benzodiazepines; Drug: TRI476; Drug: Placebo to TRI476

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975715

CTRI476B1301

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No 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.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 2 patient groups, including a placebo group

TRI476

Experimental group

Description:

Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.

Treatment:

Drug: Benzodiazepines

Drug: TRI476

Placebo

Placebo Comparator group

Description:

Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.

Treatment:

Drug: Benzodiazepines

Drug: Placebo to TRI476