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

Primary Purpose

Partial Onset Seizures

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Oxcarbazepine

About this trial

This is an interventional treatment trial for Partial Onset Seizures focused on measuring Seizures, oxcarbazepine, child

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRI476

Arm Description

TRI476

Outcomes

Primary Outcome Measures

Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))

Secondary Outcome Measures

Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period

Seizure Frequency of specific duration

Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency

Percent changes in the seizure frequency by subtype

Clinical Global Impression of Change

Full Information

NCT ID

NCT01051193

First Posted

January 15, 2010

Last Updated

November 14, 2019

Sponsor

Nobelpharma

1. Study Identification

Unique Protocol Identification Number

NCT01051193

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 5, 2010 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nobelpharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partial Onset Seizures

Keywords

Seizures, oxcarbazepine, child

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRI476

Arm Type

Experimental

Arm Description

TRI476

Intervention Type

Drug

Intervention Name(s)

Oxcarbazepine

Primary Outcome Measure Information:

Title

Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))

Time Frame