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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00614549
First received: January 11, 2008
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Retention rate after 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seizure freedom for the last 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 2569
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Levetiracetam
Patients treated with Levetiracetam

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinics and hospitals.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614549

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00614549     History of Changes
Other Study ID Numbers: N01283
Study First Received: January 11, 2008
Last Updated: May 25, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra
Epilepsy
Efficacy
Safety

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014