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OpenTrials
Completed

NCT Number: NCT00614549

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Retention rate after 6 and 12 months

    Time frame: 6 and 12 months

Secondary outcomes

  1. Seizure freedom for the last 6 and 12 months

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2008
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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