Back to resultsSafety and Efficacy of Oxcarbazepine Monotherapy in Adults 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 focused on measuring partial epilepsy, oxcarbazepine, adults
Eligibility Criteria
Inclusion Criteria: 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 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
- Epilepsy Department of the Moscow Research Institute of Psychiatry
- Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
- Neurology and Neurosurgery Department of the Russian State Medical University
- Neurology Department of I.M. Sechenov Moscow Medical Academy
- Neurology Department of Pediatric faculty of the Russian State Medical University
- Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
- Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00275925
Brief Title
Safety and Efficacy of Oxcarbazepine Monotherapy in Adults 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 Adult Patients With Partial Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Seizures
Keywords
partial epilepsy, oxcarbazepine, adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (false)
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
Quality of Life assessment at baseline, last visit
Title
Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients 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
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
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
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
Epilepsy Department of the Moscow Research Institute of Psychiatry
City
Moscow
Country
Russian Federation
Facility Name
Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
City
Moscow
Country
Russian Federation
Facility Name
Neurology and Neurosurgery Department of the Russian State Medical University
City
Moscow
Country
Russian Federation
Facility Name
Neurology Department of I.M. Sechenov Moscow Medical Academy
City
Moscow
Country
Russian Federation
Facility Name
Neurology Department of Pediatric faculty of the Russian State Medical University
City
Moscow
Country
Russian Federation
Facility Name
Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
City
Moscow
Country
Russian Federation
Facility Name
Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures
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