A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Phase 4

Completed

• Conditions: Epilepsy

• Registration Number: NCT00631150
• Lead Sponsor: UCB Pharma

Brief Summary

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Status Verified: 2009-09
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion Criteria

• hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and the tolerability of Keppra in a broad population of patients.

Secondary Outcome Measures

Name	Time	Method
Obtain further information about optimal daily dose.