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

This study has been completed.

Sponsor:

Information provided by:

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00160615

First received: September 8, 2005

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

September 14, 2009

Start Date ^ICMJE

September 2001

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of AE/ADR

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00160615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Seizures frequency per week

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Epilepsy, Partial

Intervention ^ICMJE

Drug: levetiracetam

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00160615

Other Study ID Numbers ^ICMJE

N01020, L05/EPI/LG1/FN/01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

Information Provided By

UCB, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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