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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00160654

Purpose

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Levetiracetam	Phase IV

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase IV, Open-Label, Multi-Center, Community-Based Trial Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy.

Further study details as provided by UCB:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	345
Study Start Date:	November 2003
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (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 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: NCT00160654

Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

Beh Kevin, MD

UCB

More Information

Study ID Numbers:	N01036
Study First Received:	September 8, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00160654
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by UCB:

Epilepsy
Partial Onset Seizures
Keppra
Levetiracetam

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Seizures

Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Nervous System Diseases

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009