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 (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00175890
First received: September 9, 2005
Last updated: July 6, 2015
Last verified: July 2015
  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
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Pharma:

Primary Outcome Measures:
  • Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.


Secondary Outcome Measures:
  • Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).

  • Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.

  • Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).

  • Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.

  • Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).

  • Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]
    A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electroclinical seizures plus electrographic seizures.

  • Percentage of drop-outs for any reasons during the study [ Time Frame: During the study (up to 20 days) ] [ Designated as safety issue: No ]
  • Percentage of drop-outs due to lack of efficacy during the study [ Time Frame: During the study (up to 20 days) ] [ Designated as safety issue: No ]
  • Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy [ Time Frame: During the study (up to 20 days) ] [ Designated as safety issue: No ]
  • Time to Exit (TTE) during the Evaluation Period [ Time Frame: During Evaluation Period (Day 1 to Day 6) ] [ Designated as safety issue: No ]
    For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation - the day of randomization + 1. For completed subjects, the TTE was censored on Day 6.


Enrollment: 116
Study Start Date: October 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Other: Placebo
Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
Experimental: Levetiractem
10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Drug: Levetiracetam
Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
Other Name: Keppra

  Eligibility

Ages Eligible for Study:   1 Month to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175890     History of Changes
Other Study ID Numbers: N01009, 2004-000199-14
Study First Received: September 9, 2005
Last Updated: July 6, 2015
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 Pharma:
Partial Onset Seizure
levetiracetam
Video Electroencephalogram
Keppra

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015