Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00275912

Purpose

This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.

Condition	Intervention	Phase
Epilepsy, Partial Seizures	Drug: Oxcarbazepine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 24-Week Prospective Open-Label Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Epileptic activity at electroencephalography in rest
Flash light and hyperventilation test with electroencephalography
Frequency of epileptic episodes according to patient's diary
Electrocardiogram analysis for rhythm and conduction
Blood test for sodium, hepatic enzymes and blood cells

Secondary Outcome Measures:

Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures
Rate of patients with total and partial control of epilepsy
Rate of patients requiring additional antiepileptic drugs

Estimated Enrollment:	60
Study Start Date:	December 2005
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

males and females, 6 months - 17 years of age;
diagnosis of epilepsy, partial seizures;
ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy

Exclusion Criteria:

progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
non-epileptic seizures;
drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275912

Locations

Russian Federation
Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1
Ekaterinburg, Russian Federation
Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system
Moscow, Russian Federation
Russian State Medical University clinically based on Russian Pediatric Clinical Hospital
Moscow, Russian Federation
Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russian Federation
St. Petersburg State Pediatrics Medical Academy
St Petersburg, Russian Federation

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00275912 History of Changes
Other Study ID Numbers:	CTRI476BRU02
Study First Received:	January 11, 2006
Last Updated:	December 4, 2007
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Seizures
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