Efficacy and Safety of Levetiracetam in Routine Clinical Practice in Czech and Slovak Republics, Hungary, and Romania.

Epilepsy Clinical Trial

Official title:

Long-term Evaluation of the Efficacy and Safety of Levetiracetam in Routine Clinical Practice in the Czech and Slovak Republics, Hungary, and Romania - Non-interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614549
• Other study ID #: N01283
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: May 25, 2012
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: May 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlHungary: National Institute of PharmacyRomania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2569
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate after 6 and 12 months		6 and 12 months	No
Secondary	Seizure freedom for the last 6 and 12 months		6 and 12 months	No