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: October 28, 2013
Last verified: October 2013
  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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRI476 Drug: Oxcarbazepine

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051193

Locations
Japan
#3
Bunkyo, Japan
#6
Fukuoka, Japan
#2
Kobe, Japan
#1
Neyagawa, Japan
#5
Okayama, Japan
#4
Yokohama, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01051193     History of Changes
Other Study ID Numbers: CTRI476B1301E1
Study First Received: January 15, 2010
Last Updated: October 28, 2013
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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014