Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2003-03-31

Brief Summary

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Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levetiracetam (LEV)

LEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day.

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

* high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
* low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less

Placebo

Subjects received Placebo matching to LEV treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Interventions

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Levetiracetam

* high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
* low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less

Intervention Type DRUG

Placebo

Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was \>= 6 months before the Selection Visit
* epilepsy was classifiable according to the ILAE Classification
* \>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have \>= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
* unsatisfactory current AED treatment in terms of efficacy and/or safety
* stable AED treatment consisting of no more than two AEDs

Exclusion Criteria

* treatable seizure etiology
* epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
* history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
* history of or the presence of pseudo seizures
* current diagnosis of Lennox-Gastaut syndrome

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No