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

This study is enrolling participants by invitation only.

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00614549

Purpose

To evaluate, over a period of 2 years, the efficacy and safety of newly prescribed levetiracetam as add-on treatment (partial onset seizures and juvenile myoclonic epilepsy) or primary or secondary monotherapy (partial onset seizures only) in adult patients as well as in children within the approved age limits in routine clinical practice in Czech and Slovak Republics, Hungary, Romania and Bulgaria. Non-interventional study.

Condition
Epilepsy

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Long-Term Evaluation of Efficacy and Safety of Levetiracetam in Routine Clinical Practice in the Czech and Slovak Republics, Hungary, Romania and Bulgaria - Non-Interventional Study

Further study details as provided by UCB:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3500
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 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 with or without secondary generalisation or Juvenile Myoclonic Epilepsy (JME)
newly prescribed levetiracetam as add-on treatment (partial onset seizures and JME) or primary or secondary monotherapy (partial onset seizures only)
age 4 years or above for partial onset seizures, 12 years or above for JME, 16 years or above for monotherapy

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

Locations

United States, Georgia
UCB Pharma
Smyrna, Georgia, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( UCB Clinical Trial Call Center )
Study ID Numbers:	N01283
Study First Received:	January 11, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00614549
Health Authority:	Bulgaria: Ministry of Health; 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:

Levetiracetam
Keppra
Epilepsy
Efficacy

Safety
Czech
Slovak

Study placed in the following topic categories:

Epilepsy
Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Nervous System Diseases

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009