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CompletedNCT00614549Updated May 28, 2012

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

An observational study in Epilepsy, sponsored by UCB Pharma. Completed. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2012-05-28.

Sponsored by UCB Pharma · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,569
Ages
4 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • Levetiracetam
  • Keppra
  • Epilepsy
  • Efficacy
  • Safety
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 2,569 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinics and hospitals.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,569 participants (actual)

Groups and cohorts

  • Levetiracetam

    Patients treated with Levetiracetam

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00614549
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Feb 13, 2008
Start date
Mar 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
May 28, 2012

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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