Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

Study Overview
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Brief Summary
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This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.

Official Title
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A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy

Conditions
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Partial Onset Seizures

Intervention / Treatment
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* Drug: Oxcarbazepine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who completed the double-blind treatment phase of the core study (B1301). A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age. Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301. Exclusion Criteria: Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site. Patients who participated in the core study, but did not complete it (prematurely discontinued) Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRI476<br>TRI476 | Drug: Oxcarbazepine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) |  | 52 weeks and until approval/launch | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period |  | 52 weeks and until approval/launch | 
| Seizure Frequency of specific duration |  | 52 weeks and until approval/launch | 
| Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency |  | 52 weeks and until approval/launch | 
| Percent changes in the seizure frequency by subtype |  | 52 weeks and until approval/launch | 
| Clinical Global Impression of Change |  | 52 weeks and until approval/launch | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seizures, oxcarbazepine, child