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

Condition(s) targeted: Epilepsy, Partial

Intervention: Levetiracetam (Keppra) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB

Official(s) and/or principal investigator(s):
Françoise Tonner, MD, Study Director, Affiliation: UCB

The 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.

Official title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Study design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome:

To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.

Efficacy measured by weekly seizure frequency.

Secondary outcome: To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients

Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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).

Starting date: February 1998
Ending date: January 2006
Last updated: March 7, 2008