Official Title: “A Multicenter, Open, Long-Term Follow-up Study to Evaluated the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in b.i.d. Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study.”

This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed a previous study.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2010

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam
  • 250mg tablets/500mg tablets, 500 mg/day, 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day, bid (morning and evening) PO.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levetiracetam

Primary Measures

• The long-term safety of L059 at the dose range from 500 to 3000 mg/day in subjects who participated in the preceding studies N01020 and N01021.
  • Time Frame: from the date of the study initiation until the date of approval
    Safety Issue?: No

Secondary Measures

• Percent Reduction from Baseline in the preceding study in Partial Seizure Frequency per Week.
  • Time Frame: the first period of the study
    Safety Issue?: No
• Seizures Frequency per Week in Partial Seizures over the first period.
  • Time Frame: the first period of the study
    Safety Issue?: No
• Responder rate
  • Time Frame: the first period of the study
    Safety Issue?: No
• Percent reduction from baseline according to Type of Partial Epileptic Seizures.
  • Time Frame: the first period of the study
    Safety Issue?: No

Inclusion Criteria:

• Patients who participated in the N01221 study and completed the evaluation period and transition period or patients who participated in the N01020 study.

Exclusion Criteria:

• Female patients during pregnancy, delivery and lactation or suspected of pregnancy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367432

Study ID Number: N01222

ClinicalTrials.gov Identifier: NCT00367432

Health Authority: Japan: Ministry of Health, Labor and Welfare