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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01051193
Recruitment Status : Active, not recruiting
First Posted : January 18, 2010
Last Update Posted : June 7, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Partial Onset Seizures Drug: Oxcarbazepine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 5, 2010
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: TRI476
Drug: Oxcarbazepine

Primary Outcome Measures :
  1. Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) [ Time Frame: 52 weeks and until approval/launch ]

Secondary Outcome Measures :
  1. 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 ]
  2. Seizure Frequency of specific duration [ Time Frame: 52 weeks and until approval/launch ]
  3. 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 ]
  4. Percent changes in the seizure frequency by subtype [ Time Frame: 52 weeks and until approval/launch ]
  5. Clinical Global Impression of Change [ Time Frame: 52 weeks and until approval/launch ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01051193

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01051193     History of Changes
Other Study ID Numbers: CTRI476B1301E1
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis 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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents