Clinical trial

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

Name

N157

Description

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.

Trial arms

Trial start

1998-01-26

Estimated PCD

2006-01-25

Trial end

2006-01-25

Status

Completed

Phase

Early phase I

Treatment

Levetiracetam

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

Arms:

N01010+N151 LEV/LEV, N01052 LEV/LEV, N159 LEV/LEV, N159 PBO/LEV

Other names:

Keppra

Size

223

Primary endpoint

Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period

During the Treatment Period (an average of 2 years), compared to Baseline

Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period

During the Treatment Period (an average of 2 years), compared to Baseline

Eligibility 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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 223, 'type': 'ACTUAL'}}

Updated at

2024-02-09

1 organization

1 product

2 indications

Organization

Product

Indication

Indication