Double-Blind, Placebo-Controlled Study of Levetiracetam in Adults With POS - Full Text View

Purpose

clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Levetiracetam	Phase III

Genetics Home Reference related topics:

autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics:

Epilepsy Seizures

ChemIDplus related topics:

Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	A Double-Blind, Placebo-Controlled, Randomized Study: 16-Week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as Add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures.

Further study details as provided by UCB:

Primary Outcome Measures:

The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance)

Secondary Outcome Measures:

Seizure freedom ;
The partial onset (type I) seizure reduction response rate ;
Safety and tolerability

Estimated Enrollment:	192
Study Start Date:	July 2004
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

subject suffering from partial onset seizures, whether or not secondarily generalized,
presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type IA, IB or IC) with or without secondary generalization.
subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).
subject who has been exposed to at least one classical AEDs,
CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.

Exclusion Criteria:

history of status epilepticus within three months prior to the Selection visit,
subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),
use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed.,
history or presence of pseudoseizures,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152373

Sponsors and Collaborators

UCB

Investigators


Study Director:	Yang Shally, MD	UCB

More Information

Study ID Numbers:	N01102
First Received:	September 7, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00152373
Health Authority:	China: State Food and Drug Administration

Keywords provided by UCB:

Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam

Study placed in the following topic categories:

Epilepsies, Partial

Epilepsy

Seizures

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 October 07, 2008

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00152373