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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01051193
First received: January 15, 2010
Last updated: July 21, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Partial Onset Seizures
Drug: Oxcarbazepine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Seizure Frequency of specific duration [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percent changes in the seizure frequency by subtype [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2010
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRI476
TRI476
Drug: Oxcarbazepine

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051193

Locations
Japan
Novartis Investigative Site
Nagoya-shi, Aichi, Japan, 460-0004
Novartis Investigative Site
Obu-city, Aichi, Japan, 474-8710
Novartis Investigative Site
Matsuyama, 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
Higashimatsuyama-shi, Saitama, Japan, 355-0008
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, 339-8551
Novartis Investigative Site
Yamagata, Japan, 990-0876
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01051193     History of Changes
Other Study ID Numbers: CTRI476B1301E1 
Study First Received: January 15, 2010
Last Updated: July 21, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Seizures
oxcarbazepine
child

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2016