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Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00275912
First received: January 11, 2006
Last updated: February 20, 2017
Last verified: February 2017
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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:


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

Enrollment: 60
Actual Study Start Date: September 11, 2006
Study Completion Date: September 28, 2007
Primary Completion Date: September 28, 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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: NCT00275912

Locations
Russian Federation
Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1
Ekaterinburg, Russian Federation
Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russian Federation
Russian State Medical University clinically based on Russian Pediatric Clinical Hospital
Moscow, Russian Federation
Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system
Moscow, Russian Federation
St. Petersburg State Pediatrics Medical Academy
St Petersburg, Russian Federation
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00275912     History of Changes
Other Study ID Numbers: CTRI476BRU02
Study First Received: January 11, 2006
Last Updated: February 20, 2017

Additional relevant MeSH terms:
Seizures
Epilepsies, Partial
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 April 28, 2017