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A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: September 6, 2005
Last updated: February 14, 2017
Last verified: February 2017
The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Condition Intervention Phase
Epilepsy, Partial Drug: Levetiracetam (Keppra) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.
  • Efficacy measured by weekly seizure frequency.

Secondary Outcome Measures:
  • To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients

Estimated Enrollment: 238
Study Start Date: February 1998
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
  • Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion Criteria:

  • Not be on a ketogenic diet (during the course of this study).
  • Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).
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Please refer to this study by its identifier: NCT00150709

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information: Identifier: NCT00150709     History of Changes
Other Study ID Numbers: N157
Study First Received: September 6, 2005
Last Updated: February 14, 2017

Keywords provided by UCB Pharma:
Epilepsy, Pediatric , partial onset epilepsy,
Levetiracetam (Keppra®)

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on August 18, 2017