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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630968
First Posted: March 7, 2008
Last Update Posted: November 15, 2013
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.
Information provided by:
UCB Pharma
  Purpose
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
Epilepsy Drug: Levetiracetam (Keppra) Phase 4

Study Type: Interventional
Study Design: 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

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630968


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

Additional Information:
Publications:
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00630968     History of Changes
Other Study ID Numbers: N01031
First Submitted: February 27, 2008
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
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs