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

Epilepsy Clinical Trial

Official title:

Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630968
• Other study ID #: N01031
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2008
• Last updated: November 14, 2013
• Start date: August 2000
• Est. completion date: February 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1541
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Levetiracetam (Keppra)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (3)

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 i — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction in seizure frequency.		16-week treatment period
Secondary	To further assess safety.
Secondary	The patient-weighted Quality Of Life In Epilepsy inventory.

External Links

•   Clinical Study Summary on UCB.com