NCT01086501
Completed
Not Applicable
Efficacy and Safety of an ER-formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients Under Consideration of Quality of Life Parameters
ConditionsEpilepsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Desitin Arzneimittel GmbH
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- tolerability and safety
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures
- •mono- or combination therapy
- •male and female from the age of 6
Exclusion Criteria
- •hypersensitivity to oxcarbazepine MR or one of its excipients
Outcomes
Primary Outcomes
tolerability and safety
Time Frame: 12 months per patient
Study Sites (1)
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