A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Partial

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150709

N157

Details and patient eligibility

About

Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Enrollment: 223 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
• Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion criteria

• Not be on a ketogenic diet (during the course of this study).
• Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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223 participants in 4 patient groups

N159 PBO/LEV

Experimental group

Description:

Subjects had previously participated in study N159 in which they had received Placebo (PBO).

Treatment:

Drug: Levetiracetam

N159 LEV/LEV

Experimental group

Description:

Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).

Treatment:

Drug: Levetiracetam

N01010+N151 LEV/LEV

Experimental group

Description:

Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).

Treatment:

Drug: Levetiracetam

N01052 LEV/LEV

Experimental group

Description:

Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).

Treatment:

Drug: Levetiracetam