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

Primary Purpose

Epilepsy, Partial

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Levetiracetam

Placebo

About this trial

This is an interventional treatment trial for Epilepsy, Partial focused on measuring Partial Onset Seizure, levetiracetam, Video Electroencephalogram, Keppra

Eligibility Criteria

1 Month - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Levetiractem

Arm Description

Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

Outcomes

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)

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)

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

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

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

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

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

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

Percentage of drop-outs due to lack of efficacy during the study

Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy

Time to Exit (TTE) during the Evaluation Period

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.

Full Information

NCT ID

NCT00175890

First Posted

September 9, 2005

Last Updated

September 29, 2020

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00175890

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Partial

Keywords

Partial Onset Seizure, levetiracetam, Video Electroencephalogram, Keppra

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

Arm Title

Levetiractem

Arm Type

Experimental

Arm Description

10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

Intervention Type

Drug

Intervention Name(s)

Levetiracetam

Other Intervention Name(s)

Keppra

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo solution, which is indistinguishable from the Levetiracetam oral solution.

Primary Outcome Measure Information:

Title

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)

Description

Time Frame