ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT01086501
- Lead Sponsor
- Desitin Arzneimittel GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method tolerability and safety 12 months per patient
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the antiepileptic effects of oxcarbazepine extended release formulation in focal epilepsy patients?
How does the efficacy of oxcarbazepine ER compare to standard-of-care anticonvulsants like lamotrigine or levetiracetam in partial seizure management?
Are there specific biomarkers associated with improved seizure control and quality of life outcomes in oxcarbazepine ER-treated epilepsy patients?
What are the long-term adverse event profiles and management strategies for oxcarbazepine extended release in chronic epilepsy therapy?
How does oxcarbazepine ER's pharmacokinetic profile influence its role in combination therapy with other antiepileptic drugs like valproate or carbamazepine?
Trial Locations
- Locations (1)
Dr. Stephan Arnold
🇩🇪Munich, Bavaria, Germany
Dr. Stephan Arnold🇩🇪Munich, Bavaria, Germany