A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00105040
First received: March 3, 2005
Last updated: December 5, 2013
Last verified: February 2010
  Purpose

A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.


Condition Intervention Phase
Epilepsy, Partial
Drug: Levetiracetam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 19-week, Randomized, Double-blind, Multicenter, Placebo-controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20 - 60 mg/kg/Day, Divided in Twice Daily Dosing, as Adjunctive Treatment in Children 4 - 16 Years Old, Inclusive, With Refractory Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Characterize potential cognitive and neuropsychological effects of levetiracetam as adjunctive treatment in children 4-16 years old with refractory partial onset seizures compared to placebo attention/memory scale (Leiter-R) a

Secondary Outcome Measures:
  • Scores on memory/learning battery (WRAML-2), behavioral scale (CBCL), and quality of life scale (CHQ) after 12 weeks of double blind treatment

Estimated Enrollment: 87
Study Start Date: September 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Pediatric subjects (4 - 16 years old) diagnosed with refractory partial onset seizures for a minimum of six months prior to Visit 1 experiencing at least two partial onset seizures during the four weeks prior to Visit 1 will be enrolled.
  • Subjects should be on a stable regimen of one or a maximum of two other AEDs for at least 2 weeks prior to Visit 1.
  • Subject must have an Intelligence Quotient (IQ) as assessed during Visit 1 of at least 70.
  • Subject and parent/guardian should be fluent in English.

Exclusion Criteria:

  • Subject must not have had previous treatment with levetiracetam unless, in the opinion of the investigator, the subject's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of levetiracetam was confounded by concomitant medication.
  • Subject is receiving benzodiazepines on a routine or chronic basic and is unable to discontinue use four weeks prior to Visit 1.
  • Subject has seizures too close together to accurately count.
  • Subject has a current psychiatric disorder other than mild to moderate attention deficit, behavior, or learning disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105040

  Show 45 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00105040     History of Changes
Other Study ID Numbers: N01103
Study First Received: March 3, 2005
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by UCB, Inc.:
Partial onset seizures
epilepsy
levetiracetam
Keppra
cognition
behavior
pediatry

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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 July 31, 2014