Official Title: “Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy”

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study - to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development - to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Study Type: Interventional

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

Study Primary Completion Date: May 2003

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam

Primary Measures

• Adverse event rates, seizure counts and quality of life.
  • Time Frame: 16 week treatment period
    

Inclusion Criteria:

• Male and female older than 16 years;
• Epilepsy with partial onset seizures, with or without secondary generalization;
• At least one concomitant marketed anti-epileptic drug

Exclusion Criteria:

• Safety reasons

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

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

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643500

Study ID Number: N01033

ClinicalTrials.gov Identifier: NCT00643500

Health Authority: Spain: Spanish Agency of Medicines