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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630968
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 15, 2013
Information provided by:
UCB Pharma

February 27, 2008
March 7, 2008
November 15, 2013
August 2000
February 2004   (Final data collection date for primary outcome measure)
Percentage reduction in seizure frequency. [ Time Frame: 16-week treatment period ]
Same as current
Complete list of historical versions of study NCT00630968 on Archive Site
  • To further assess safety.
  • The patient-weighted Quality Of Life In Epilepsy inventory.
Same as current
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S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
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.
Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Levetiracetam (Keppra)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2004
February 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Study Director, UCB
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP