A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00175890
First received: September 9, 2005
Last updated: September 16, 2013
Last verified: September 2009
  Purpose

To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.


Condition Intervention Phase
Epilepsy, Partial
Drug: levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age. N01009

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Responder Rate for total partial onset seizures defined as the number of subjects with a greater than or equal to 50% reduction in average daily frequency of partial onset seizures recorded on 48-hour EEG video.

Secondary Outcome Measures:
  • Responder rate for total seizures (all types) for completed subjects and dropouts
  • Percent reduction and absolute reduction 1. average daily frequency (ADF) of partial onset seizures and 2. ADF of total seizures

Estimated Enrollment: 110
Study Start Date: October 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 4 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Pediatric patients from 1 month to less than 4 years of age.
  • Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening.
  • Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening.

Exclusion Criteria:

  • A ketogenic diet
  • Previous exposure to levetiracetam
  • Seizures too close together to count accurately
  • Treatable seizure etiology
  • Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease
  • Diagnosis of a terminal illness
  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: NCT00175890

  Show 88 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00175890     History of Changes
Other Study ID Numbers: N01009, EudraCT 2004-000199-14
Study First Received: September 9, 2005
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Brazil: National Health Surveillance Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Partial Onset Seizure
levetiracetam
Video Electroencephalogram
Keppra

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 August 27, 2014