Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

This study has been completed.

First Received on February 21, 2008. Last Updated on September 14, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00643500

Purpose

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Levetiracetam	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Adverse event rates, seizure counts and quality of life. [ Time Frame: 16 week treatment period ]

Enrollment:	342
Study Start Date:	January 2002
Study Completion Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643500

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	Study Director, UCB
ClinicalTrials.gov Identifier:	NCT00643500 History of Changes
Other Study ID Numbers:	N01033
Study First Received:	February 21, 2008
Last Updated:	September 14, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by UCB, Inc.:

Levetiracetam
Keppra

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam

Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on February 09, 2012