Efficacy and Safety of Levetiracetam in Routine Clinical Practice in Czech and Slovak Republics, Hungary, and Romania.
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00614549
- Lead Sponsor
- UCB Pharma
- Brief Summary
To evaluate, over 1 year period, the efficacy and safety of newly prescribed levetiracetam as add-on treatment (POS, myoclonoc seizures in JME and PGTCS in IGE) or primary monotherapy (partial onset seizures) in adult and paediatric patients within the approved age limits in routine clinical practice in Czech and Slovak Republics, Hungary, and Romania. Non-interventional study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2569
Inclusion Criteria
- diagnoses of partial onset seizures (POS) with or without secondary generalisation or Juvenile Myoclonic Epilepsy (JME) or another IGE with PGTCS
- newly prescribed levetiracetam as add-on treatment (POS, myoclonic seizures in JME and PGTCS in IGE) or monotherapy (partial onset seizures only) in newly diagnosed patients. Newly prescribed means inclusion of the patients in whom a decision has been made to prescribe LEV and the first dose is just to be prescribed.
- age 4 years or above for partial onset seizures, 12 years or above for MS in JME or PGTCS in IGE, 16 years or above for monotherapy
- patient written informed consent
Exclusion Criteria
- indications other than those defined in inclusion criteria
- history of allergic or anaphylactic reactions to levetiracetam or other pyrrolidone derivatives and excipients included
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Retention rate after 6 and 12 months 6 and 12 months
- Secondary Outcome Measures
Name Time Method Seizure freedom for the last 6 and 12 months 6 and 12 months