NCT00160615 - Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method | Crick | Crick

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

Phase 3CompletedNCT00160615

UCB Japan Co. Ltd.154 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

154

Conditions

Epilepsy, Partial

Interventions

LevetiracetamDRUG

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Partial (Type I) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

Time frame: From Baseline up to 54 months

Partial (Type IA) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

Time frame: From Baseline up to 54 months

Partial (Type IB) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

Time frame: From Baseline up to 54 months

Partial (Type IC) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

Time frame: From Baseline up to 54 months

Secondary Outcomes

Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit

Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.

Time frame: From Baseline up to 54 months

Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit

Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.

Time frame: From Baseline up to 54 months

Data from ClinicalTrials.gov

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