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

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ClinicalTrials.gov Identifier: NCT00175890
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE October 2004
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
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.
Change History Complete list of historical versions of study NCT00175890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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) ]
  • Percentage of drop-outs due to lack of efficacy during the study [ Time Frame: During the study (up to 20 days) ]
  • 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) ]
  • Time to Exit (TTE) during the Evaluation Period [ Time Frame: During Evaluation Period (Day 1 to Day 6) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, Partial
Intervention  ICMJE
  • 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
  • Other: Placebo
    Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
    Intervention: Other: Placebo
  • Experimental: Levetiractem
    10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
    Intervention: Drug: Levetiracetam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2015)
116
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
110
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Mexico,   Poland,   Romania,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00175890
Other Study ID Numbers  ICMJE N01009
2004-000199-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center UCB Pharma
PRS Account UCB Pharma
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP