Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Community based study assessing safety and efficacy of levetiracetam in partial onset seizures. The optimal dose in daily clinical practice will be used...
Brief Summary
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: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
- Study Primary Completion Date: May 2006
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam
Outcome Measures for this Clinical Trial
Primary Measures
- To assess safety of levetiracetam
Secondary Measures
- To evaluate efficacy of levetiracetam in community based practice.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Related Publications
Citations Reporting Results
Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, Tonner F, Beh K, Edrich P; on behalf of the N01036 (SKATE II) Investigator Group. Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: The Asia SKATE II Study. Epilepsy Behav. 2010 May 10; [Epub ahead of print]
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00160654
