Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

This study is currently recruiting participants.

Verified by UCB, August 2009

First Received: July 20, 2007 Last Updated: August 13, 2009 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00505934

Purpose

Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the pharmacokinetics, safety and tolerability of this formulation in children aged 1 month to 4 years.

Condition	Intervention	Phase
Epilepsy	Drug: Levetiracetam	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy.

Resource links provided by NLM:

Genetics Home Reference related topics: 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:

Primary Outcome Measures:

Adverse events, local tolerability at the site of infusion, body weight, vital signs, 12-lead ECG recordings, physical and neurological examinations, laboratory tests (blood-hematology and biochemistry). [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The concentration of levetiracetam in plasma samples. [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	May 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Levetiracetam: Experimental	Drug: Levetiracetam Intravenous 100mg/mL BID, maximum 4 days

Eligibility

Ages Eligible for Study:	1 Month to 4 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female between 1 month and 4 years of age, inclusive.
The subject suffers from epilepsy (except status epilepticus)
The subject is requiring levetiracetam IV treatment for a short period of time

Exclusion Criteria:

The subject has difficult venous accessibility
History of status epilepticus during the 3 months prior to Screening
The subject is on felbamate with less than 18 months continuous exposure before Screening.
The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505934

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Locations

United States, California
	Recruiting
San Diego, California, United States
United States, New York
	Recruiting
Buffalo, New York, United States
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States
United States, Texas
	Recruiting
Fort Worth, Texas, United States
United States, Virginia
	Recruiting
Richmond, Virginia, United States
Belgium
	Recruiting
Gent, Belgium
	Recruiting
Leuven, Belgium
France
	Suspended
Amiens, France
	Suspended
Lille, France
	Suspended
Paris, France
	Suspended
Vandoeuvre Les Nancy, France
Germany
	Recruiting
Heidelberg, Germany
	Recruiting
Kehl, Germany
	Recruiting
Kiel, Germany

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01275, EudraCT NUmber 2007-003517-13
Study First Received:	July 20, 2007
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00505934 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB:

Epilepsy
Child
Levetiracetam
Keppra
Injection

Study placed in the following topic categories:

Nootropic Agents
Epilepsy
Piracetam
Central Nervous System Diseases

Etiracetam
Brain Diseases
Neuroprotective Agents
Anticonvulsants

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on September 11, 2009