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

Last updated: March 8, 2019
Sponsor: UCB Japan Co. Ltd.
Overall Status: Completed

Phase

3

Condition

Epilepsy

Seizure Disorders

Treatment

N/A

Clinical Study ID

NCT00160615
N01020
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 N165Follow-up Study, and also the investigator admit the necessity of the repeated intakeof the investigational drug for the patients.

Exclusion

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 ofentering the follow-up study taking the same medication.

  • Patients had not been in compliance with requirements of Protocol for N165 ClinicalTrial of L059 in the course of the study.

Study Design

Total Participants: 154
Study Start date:
September 12, 2001
Estimated Completion Date:
January 17, 2007