S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development...
Brief Summary
Official Title: “Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy”
The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: February 2004
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam (Keppra)
Outcome Measures for this Clinical Trial
Primary Measures
- Percentage reduction in seizure frequency.
- Time Frame: 16-week treatment period
- Time Frame: 16-week treatment period
Secondary Measures
- To further assess safety.
- The patient-weighted Quality Of Life In Epilepsy inventory.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Partial onset seizures, whether or not secondarily generalized;
- at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
- using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.
Exclusion Criteria:
- Presence of known pseudoseizures within the last year;
- presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
- on felbamate with less than 18 months exposure;
- on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
- uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.
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
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)
Related Publications
Citations Reporting Results
Steinhoff BJ, Somerville ER, Van Paesschen W, Ryvlin P, Schelstraete I. The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. Epilepsy Res. 2007 Aug;76(1):6-14. Epub 2007 Aug 6.
Somerville ER, McLaughlin DB, Robinson MK, Berkovic SF. Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients. Epilepsy Behav. 2007 Nov;11(3):338-42. Epub 2007 Sep 11.
Genton P, Sadzot B, Fejerman N, Peltola J, Despland PA, Steinhoff B, Rektor I, Wroe S, Maubrey MC, Vandervelden C, van Hammée G, Schlit AF, van Paesschen W. Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial. Acta Neurol Scand. 2006 Jun;113(6):387-94.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630968
Study ID Number: N01031
ClinicalTrials.gov Identifier: NCT00630968
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00630968
