Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
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
1 other identifier
interventional
60
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2006
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2006
CompletedFirst Posted
Study publicly available on registry
January 12, 2006
CompletedStudy Start
First participant enrolled
September 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2007
CompletedFebruary 23, 2017
February 1, 2017
1 year
January 11, 2006
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russia
Russian State Medical University clinically based on Russian Pediatric Clinical Hospital
Moscow, Russia
Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system
Moscow, Russia
St. Petersburg State Pediatrics Medical Academy
Saint Petersburg, Russia
Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1
Yekaterinburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2006
First Posted
January 12, 2006
Study Start
September 11, 2006
Primary Completion
September 28, 2007
Study Completion
September 28, 2007
Last Updated
February 23, 2017
Record last verified: 2017-02