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

UCB logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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