Safety and Efficacy of Oxcarbazepine Monotherapy in Adults 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 Adult Patients With Partial Seizures
1 other identifier
interventional
80
1 country
7
Brief Summary
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.
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 Dec 2005
7 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
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 11, 2006
CompletedFirst Posted
Study publicly available on registry
January 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedNovember 30, 2007
November 1, 2007
January 11, 2006
November 29, 2007
Conditions
Keywords
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 (4)
Quality of Life assessment at baseline, last visit
Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients 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, 18 - 70 years of age;
- diagnosis of epilepsy, partial seizures;
- ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs
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 (7)
Epilepsy Department of the Moscow Research Institute of Psychiatry
Moscow, Russia
Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
Moscow, Russia
Neurology and Neurosurgery Department of the Russian State Medical University
Moscow, Russia
Neurology Department of I.M. Sechenov Moscow Medical Academy
Moscow, Russia
Neurology Department of Pediatric faculty of the Russian State Medical University
Moscow, Russia
Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
Moscow, Russia
Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute
Saint Petersburg, 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
Study Record Dates
First Submitted
January 11, 2006
First Posted
January 12, 2006
Study Start
December 1, 2005
Study Completion
March 1, 2007
Last Updated
November 30, 2007
Record last verified: 2007-11