S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

• ClinicalTrials.gov Identifier: NCT00630968
• Recruitment Status: Completed
• First Posted: March 7, 2008
• Last Update Posted: November 15, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: Levetiracetam (Keppra)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1541 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy
• Study Start Date: August 2000
• Actual Primary Completion Date: February 2004
• Actual Study Completion Date: February 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Percentage reduction in seizure frequency. [ Time Frame: 16-week treatment period ]

Secondary Outcome Measures :

1. To further assess safety.
2. The patient-weighted Quality Of Life In Epilepsy inventory.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

UCB Pharma

Investigators

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

More Information

Publications of 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. doi: 10.1016/j.eplepsyres.2007.06.002. 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. doi: 10.1016/j.yebeh.2007.06.005. 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 Hammee 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. doi: 10.1111/j.1600-0404.2006.00647.x.

• Responsible Party: Study Director, UCB
• ClinicalTrials.gov Identifier: NCT00630968
• Other Study ID Numbers: N01031
• First Posted: March 7, 2008
• Last Update Posted: November 15, 2013
• Last Verified: September 2009

Keywords provided by UCB Pharma:

Levetiracetam; Keppra

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Levetiracetam; Anticonvulsants; Nootropic Agents