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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: September 14, 2009
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630968

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

Publications:

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00630968     History of Changes
Other Study ID Numbers: N01031
Study First Received: February 27, 2008
Last Updated: September 14, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013