Official Title: “A Multicenter, Open-Label, Follow-up Trial Evaluating the Long-Term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.”

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Study Type: Interventional

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

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: LEVETIRACETAM

Primary Measures

• Around 4 years of Safety assessment of levetiracetam via Adverse Events reporting,

Inclusion Criteria:

• Subjects with a confirmed diagnosis of epilepsy.
• Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic
• Seizures
• Subjects having participated in the previous double-blind monotherapy trial (N01061 or N01093).
• Male/female subjects (≥ 16 years).

Exclusion Criteria:

• Need for an additional AED.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

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

F Tonner, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150813

Study ID Number: N01127

ClinicalTrials.gov Identifier: NCT00150813

Health Authority: Czech Republic: State Institute for Drug Control