A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

This study has been completed.

First Received: February 27, 2008 Last Updated: September 14, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00631150

Purpose

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Condition	Intervention	Phase
Epilepsy	Drug: Levetiracetam (Keppra)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Safety and the tolerability of Keppra in a broad population of patients.

Secondary Outcome Measures:

Obtain further information about optimal daily dose.

Enrollment:	35
Study Start Date:	March 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 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 with or without secondary generalisation with epilepsy.

Exclusion Criteria:

hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631150

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01035
Study First Received:	February 27, 2008
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00631150 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by UCB, Inc.:

Levetiracetam
Keppra

Additional relevant MeSH terms:

Nootropic Agents
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neuroprotective Agents
Protective Agents

Pharmacologic Actions
Epilepsy
Therapeutic Uses
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010