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

Sponsored by:	UCB
Information provided by:	UCB
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

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

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam

U.S. FDA Resources

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

Further study details as provided by UCB:

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

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01035
Study First Received:	February 27, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00631150
Health Authority:	Greece: National Organization of Medicines

Keywords provided by UCB:

Levetiracetam
Keppra

Study placed in the following topic categories:

Epilepsy
Piracetam
Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009