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

Nobelpharma Co., Ltd.

Status and phase

Completed

Phase 3

Phase 2

Conditions

Partial Onset Seizures

Treatments

Drug: Oxcarbazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01051193

CTRI476B1301E1

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

4 to 15 years old

Volunteers

No 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/exclusion criteria may apply.