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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051193

Enrollment

Registered

2010-01-18

Start date

2010-01-05

Completion date

2019-09-30

Last updated

2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Onset Seizures

Keywords

Seizures, oxcarbazepine, child

Brief summary

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.

Interventions

DRUGOxcarbazepine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 15 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))	52 weeks and until approval/launch

Secondary

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026