Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: February 27, 2008
Last updated: November 14, 2013
Last verified: September 2009
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 Intervention Phase
Drug: Levetiracetam (Keppra)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage reduction in seizure frequency. [ Time Frame: 16-week treatment period ]

Secondary Outcome Measures:
  • To further assess safety.
  • The patient-weighted Quality Of Life In Epilepsy inventory.

Enrollment: 1541
Study Start Date: August 2000
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00630968

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: Study Director, UCB Identifier: NCT00630968     History of Changes
Other Study ID Numbers: N01031
Study First Received: February 27, 2008
Last Updated: November 14, 2013

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 28, 2017