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

September 29, 2020 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Mendoza, Argentina
      • Pilar Buenos Aires, Argentina
  • Belgium
      • Brussels, Belgium
      • Leuven, Belgium
  • Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Porto Alegre, Brazil
      • Ribeirao Preto, Brazil
      • Rio de Janeiro, Brazil
      • Sao Paulo, Brazil
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnepeg, Manitoba, Canada
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada
    • Ontario
      • London, Ontario, Canada
      • Scarborough, Ontario, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Czechia
      • Brno, Czechia
      • Praha 4, Czechia
      • Praha 5, Czechia
  • France
      • Lille Cedex, France
      • Paris, France
      • Rouen Cedex, France
      • Strasbourg Cedex, France
  • Germany
      • Berlin, Germany
      • Erlangen, Germany
      • Heidelberg, Germany
      • Jena, Germany
      • Kiel, Germany
    • Kork
      • Kehl, Kork, Germany
  • Hungary
      • Budapest, Hungary
  • Italy
      • Calambrone, Italy
      • Genoa, Italy
      • Milano, Italy
      • Roma, Italy
  • Mexico
      • Mexico City, Mexico
  • Poland
      • Gdansk, Poland
  • Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Tirgu-Mures, Romania
  • Russian Federation
      • Kalingrad, Russian Federation
      • Moscow, Russian Federation
      • Saint Petersburg, Russian Federation
      • St Petersburg, Russian Federation
  • United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Los Angeles, California, United States
    • Florida
      • Gainesville, Florida, United States
      • Loxahatchee Groves, Florida, United States
      • Miami, Florida, United States
      • Tallahassee, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Edison, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Danville, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48-hours in Evaluation Period and 48-hours in Selection Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48-hours in Evaluation Period and 48-hours in Selection Period
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.
48-hours in Evaluation Period and 48-hours in Selection Period
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).
48-hours in Evaluation Period and 48-hours in Selection Period
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.
48-hours in Evaluation Period and 48-hours in Selection Period
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).
48-hours in Evaluation Period and 48-hours in Selection Period
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.
48-hours in Evaluation Period and 48-hours in Selection Period
Percentage of drop-outs for any reasons during the study
Time Frame: During the study (up to 20 days)
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)
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)
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.
During Evaluation Period (Day 1 to Day 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01009
  • 2004-000199-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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