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

November 14, 2019 updated by: Nobelpharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu, Japan, 502-8558
        • NPC Investigative Site
      • Niigata, Japan, 950-2085
        • NPC Investigative Site
      • Saitama, Japan, 355-0008
        • NPC Investigative Site
      • Yamagata, Japan, 990-0876
        • NPC Investigative Site
    • Aichi
      • Nagoya-shi, Aichi, Japan, 460-0004
        • NPC Investigative Site
      • Obu-city, Aichi, Japan, 474-8710
        • NPC Investigative Site
    • Ehime
      • Matsuyama-city, Ehime, Japan, 790-8524
        • NPC Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 814-0180
        • NPC Investigative Site
    • Hokkaido
      • Kameda-gun, Hokkaido, Japan, 041-1111
        • NPC Investigative Site
      • Sapporo-city, Hokkaido, Japan, 060-8648
        • NPC Investigative Site
    • Hyogo
      • Himeji, Hyogo, Japan, 670-8540
        • NPC Investigative Site
      • Kobe, Hyogo, Japan, 658-0032
        • NPC Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 244-0842
        • NPC Investigative Site
    • Kumamoto
      • Koshi-city, Kumamoto, Japan, 861-1196
        • NPC Investigative Site
    • Niigata
      • Kashiwazaki, Niigata, Japan, 945-8585
        • NPC Investigative Site
    • Oita
      • Yufu, Oita, Japan, 879-5593
        • NPC Investigative Site
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8522
        • NPC Investigative Site
      • Okayama-city, Okayama, Japan, 700-8558
        • NPC Investigative Site
    • Osaka
      • Neyagawa, Osaka, Japan, 572-0085
        • NPC Investigative Site
    • Saitama
      • Saitama-city, Saitama, Japan, 330-8777
        • NPC Investigative Site
    • Shiga
      • Moriyama-shi, Shiga, Japan, 524-0022
        • NPC Investigative Site
    • Shizuoka
      • Shizuoka-city, Shizuoka, Japan, 420-8688
        • NPC Investigative Site
    • Tochigi
      • Shimotsuke-city, Tochigi, Japan, 329-0498
        • NPC Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • NPC Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRI476
Drug: Oxcarbazepine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period
Time Frame: 52 weeks and until approval/launch
52 weeks and until approval/launch
Seizure Frequency of specific duration
Time Frame: 52 weeks and until approval/launch
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
Time Frame: 52 weeks and until approval/launch
52 weeks and until approval/launch
Percent changes in the seizure frequency by subtype
Time Frame: 52 weeks and until approval/launch
52 weeks and until approval/launch
Clinical Global Impression of Change
Time Frame: 52 weeks and until approval/launch
52 weeks and until approval/launch

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nobelpharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2010

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRI476B1301E1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NPC is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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