Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

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

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-12

Study Completion Date

2007-01-17

Brief Summary

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The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

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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

This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levetiracetam

Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

* Pharmaceutical form: Film-coating tablets
* Concentration: 250 mg/ 500 mg
* Route of administration: oral use

Interventions

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Levetiracetam

* Pharmaceutical form: Film-coating tablets
* Concentration: 250 mg/ 500 mg
* Route of administration: oral use

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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Inclusion Criteria

* Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
* Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion Criteria

* Patients who had not participate in N165 Clinical Trial of L059.
* Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
* Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No