Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00160628

Purpose

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Levetiracetam	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

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:

To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).

Secondary Outcome Measures:

To assess safety of levetiracetam

Estimated Enrollment:	100
Study Start Date:	March 2004
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria:

Subjects on felbamate with less than 18 months exposure.
Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
Presence of known pseudoseizures within the last year.
Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160628

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Publications:

Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. Epub 2007 Mar 19.

ClinicalTrials.gov Identifier:	NCT00160628 History of Changes
Other Study ID Numbers:	N01099
Study First Received:	September 8, 2005
Last Updated:	February 22, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by UCB, Inc.:

Epilepsy
Partial Onset Seizures
Keppra
Levetiracetam

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 February 09, 2012