Back to resultsEfficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
Primary Purpose
Epilepsy, Partial Seizures
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Oxcarbazepine
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Partial Seizures
Eligibility 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.
Sites / Locations
- Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1
- Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery
- Russian State Medical University clinically based on Russian Pediatric Clinical Hospital
- Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system
- St. Petersburg State Pediatrics Medical Academy
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00275912
Brief Title
Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 11, 2006 (Actual)
Primary Completion Date
September 28, 2007 (Actual)
Study Completion Date
September 28, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Primary Outcome Measure Information:
Title
Epileptic activity at electroencephalography in rest
Title
Flash light and hyperventilation test with electroencephalography
Title
Frequency of epileptic episodes according to patient's diary
Title
Electrocardiogram analysis for rhythm and conduction
Title
Blood test for sodium, hepatic enzymes and blood cells
Secondary Outcome Measure Information:
Title
Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures
Title
Rate of patients with total and partial control of epilepsy
Title
Rate of patients requiring additional antiepileptic drugs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1
City
Ekaterinburg
Country
Russian Federation
Facility Name
Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery
City
Moscow
Country
Russian Federation
Facility Name
Russian State Medical University clinically based on Russian Pediatric Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system
City
Moscow
Country
Russian Federation
Facility Name
St. Petersburg State Pediatrics Medical Academy
City
St Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
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