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

NCT ID: NCT01051193

Last Updated: 2019-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-05

Study Completion Date

2019-09-30

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.

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Detailed Description

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Conditions

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Partial Onset Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRI476

TRI476

Group Type EXPERIMENTAL

Oxcarbazepine

Intervention Type DRUG

Interventions

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Oxcarbazepine

Intervention Type DRUG

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)
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nobelpharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NPC Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

NPC Investigative Site

Ōbu, Aichi-ken, Japan

Site Status

NPC Investigative Site

Matsuyama, Ehime, Japan

Site Status

NPC Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

NPC Investigative Site

Kameda-gun, Hokkaido, Japan

Site Status

NPC Investigative Site

Sapporo, Hokkaido, Japan

Site Status

NPC Investigative Site

Himeji, Hyōgo, Japan

Site Status

NPC Investigative Site

Kobe, Hyōgo, Japan

Site Status

NPC Investigative Site

Yokohama, Kanagawa, Japan

Site Status

NPC Investigative Site

Kōshi, Kumamoto, Japan

Site Status

NPC Investigative Site

Kashiwazaki, Niigata, Japan

Site Status

NPC Investigative Site

Yufu, Oita Prefecture, Japan

Site Status

NPC Investigative Site

Kurashiki, Okayama-ken, Japan

Site Status

NPC Investigative Site

Okayama, Okayama-ken, Japan

Site Status

NPC Investigative Site

Neyagawa, Osaka, Japan

Site Status

NPC Investigative Site

Saitama, Saitama, Japan

Site Status

NPC Investigative Site

Moriyama-shi, Shiga, Japan

Site Status

NPC Investigative Site

Shizuoka, Shizuoka, Japan

Site Status

NPC Investigative Site

Shimotsuke, Tochigi, Japan

Site Status

NPC Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status

NPC Investigative Site

Gifu, , Japan

Site Status

NPC Investigative Site

Niigata, , Japan

Site Status

NPC Investigative Site

Saitama, , Japan

Site Status

NPC Investigative Site

Yamagata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CTRI476B1301E1

Identifier Type: -

Identifier Source: org_study_id

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