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

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ClinicalTrials.gov Identifier: NCT00614549
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Epilepsy

Study Type : Observational
Actual Enrollment : 2569 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Group/Cohort
Levetiracetam
Patients treated with Levetiracetam



Primary Outcome Measures :
  1. Retention rate after 6 and 12 months [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Seizure freedom for the last 6 and 12 months [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614549


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00614549     History of Changes
Other Study ID Numbers: N01283
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012

Keywords provided by UCB Pharma:
Levetiracetam
Keppra
Epilepsy
Efficacy
Safety

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