Official Title: “A Phase IV, Open-Label, Multi-Center, Community-Based Trial Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy.”

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.

Study Type: Interventional

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

Study Primary Completion Date: May 2006

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam

Primary Measures

• To assess safety of levetiracetam

Secondary Measures

• To evaluate efficacy of levetiracetam in community based practice.

Inclusion Criteria:

• Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
• Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
• Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria:

• Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
• Presence of known pseudoseizures within the last year.
• Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
• Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Beh Kevin, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160654

Study ID Number: N01036

ClinicalTrials.gov Identifier: NCT00160654

Health Authority: Singapore: Health Sciences Authority