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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00630968
First received: February 27, 2008
Last updated: November 14, 2013
Last verified: September 2009

February 27, 2008
November 14, 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 ClinicalTrials.gov Archive Site
  • To further assess safety.
  • The patient-weighted Quality Of Life In Epilepsy inventory.
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: Levetiracetam (Keppra)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1541
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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00630968
N01031
No
Study Director, UCB
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
September 2009

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