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

Novartis Pharmaceuticals99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Partial Onset Seizures

Interventions

TRI476DRUG

TRI476 oral suspension doses, based on body weight twice daily

Placebo to TRI476DRUG

Placebo oral suspension, taken twice daily

BenzodiazepinesDRUG

Benzodiazepines could be used as needed as rescue medication during the duration of the study.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (25)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group

Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.

Time frame: screening and 28 days

Secondary Outcomes

Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group

Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.

Time frame: baseline, 28 days and 56 days

Percent of Participants With Response During Double-blind Phase, by Treatment Group

Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.

Time frame: screening to 28 days

Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type

Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.

Data from ClinicalTrials.gov

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