A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00150709

Purpose

The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Levetiracetam (Keppra)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Resource links provided by NLM:

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

MedlinePlus related topics: Epilepsy

Drug Information available for: Etiracetam Levetiracetam

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.
Efficacy measured by weekly seizure frequency.

Secondary Outcome Measures:

To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients

Estimated Enrollment:	238
Study Start Date:	February 1998
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion Criteria:

Not be on a ketogenic diet (during the course of this study).
Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150709

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	N157
Study First Received:	September 6, 2005
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00150709 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: Ministry of Health

Keywords provided by UCB, Inc.:

Epilepsy, Pediatric , partial onset epilepsy,
Levetiracetam (Keppra®)

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010