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

NCT ID: NCT00150709

Last Updated: 2024-02-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-26

Study Completion Date

2006-01-25

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy, Partial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N159 PBO/LEV

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

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

* Pharmaceutical form: Oral tablets and oral solution
* Route of administration: Oral use

N159 LEV/LEV

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

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

* Pharmaceutical form: Oral tablets and oral solution
* Route of administration: Oral use

N01010+N151 LEV/LEV

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

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

* Pharmaceutical form: Oral tablets and oral solution
* Route of administration: Oral use

N01052 LEV/LEV

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

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

* Pharmaceutical form: Oral tablets and oral solution
* Route of administration: Oral use

Interventions

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Levetiracetam

* Pharmaceutical form: Oral tablets and oral solution
* Route of administration: Oral use

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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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).
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Related Links

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Other Identifiers

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N157

Identifier Type: -

Identifier Source: org_study_id

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