Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00152516

Purpose

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009/N01103 or by direct enrollment) open-label levetiracetam treatment, continue studying potential cognitive and behavioral effects in children, and continue collection of safety/efficacy data.

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 pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

Further study details as provided by UCB:

Primary Outcome Measures:

To obtain long-term descriptive safety and efficacy data in pediatric epileptic patients with partial onset seizures receiving long-term treatment with levetiracetam at individualized doses. [ Time Frame: 48 weeks ]
Efficacy assessed by measuring the percentage change of Partial Type 1 seizure frequency per week over time from baseline during the treatment period [ Time Frame: 48 weeks ]

Secondary Outcome Measures:

Total and partial seizure frequency per week over time. Change from baseline of partial and total seizure frequency per week over time. [ Time Frame: 48 weeks ]
Responder rates, maximum seizure-free interval and continuously seizure-free [ Time Frame: 48 weeks ]

Enrollment:	255
Study Start Date:	October 2004
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Levetiracetam Oral Solution and tablets 20mg to 80 mg/kg/day

Eligibility

Ages Eligible for Study:	1 Month to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pediatric patients with partial onset seizures, with or without participation in previous levetiracetam pediatric studies (N01009 or N01103) for whom levetiracetam treatment will be of possible benefit

Exclusion Criteria:

Patients on a ketogenic diet
Seizures too close together to accurately count
Treatable seizure etiology
Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152516

Show 86 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01148, EudraCT number:2004-000200-40
Study First Received:	September 7, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00152516
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: National Institute of Public Health, Health Secretariat; Brazil: National Health Surveillance Agency; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Russia: Pharmacological Committee, Ministry of Health; Romania: State Institute for Drug Control

Keywords provided by UCB:

Partial Onset Seizures, levetiracetam
Epilepsy
Keppra

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 January 16, 2009