Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00975715

Purpose

This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Condition	Intervention	Phase
Partial Onset Seizures	Drug: Oxcarbazepine Drug: Placebo Comparator	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seizure Frequency of specific duration [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Percent changes in the seizure frequency by subtype [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Clinical Global Impression of Change (CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability(Adverse events, Laboratory tests, Vital signs, Electrocardiogram (ECG) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2009
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TRI476	Drug: Oxcarbazepine
Placebo Comparator: Placebo	Drug: Placebo Comparator

Eligibility

Ages Eligible for Study:	4 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).

Exclusion Criteria:

A document history of generalized status epileptics in the past 6 months.
Seizures having a metabolic, neoplastic, or active infectious origin.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975715

Contacts

Contact: Novartis Pharmaceuticals

+81-3-3797-8031

Locations

Japan
Novartis Investigative Site	Recruiting
Bunkyo, Japan
Novartis Investigative Site	Recruiting
Fukuoka, Japan
Novartis Investigative Site	Recruiting
Kobe, Japan
Novartis Investigational Site	Recruiting
Neyagawa, Japan
Novartis Investigative Site	Recruiting
Okayama, Japan
Novartis Investigative Site	Recruiting
Yokohama, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Click here for more information about this study: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Direct, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00975715 History of Changes
Other Study ID Numbers:	CTRI476B1301
Study First Received:	September 10, 2009
Last Updated:	December 7, 2010
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 February 09, 2012