Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Memphis, Tennessee 38103


Purpose:

The test article for this study is levetiracetam (Keppra, which is commercially available. Keppra is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorders in patients age four years and above. An intravenous dosage form of levetiracetam is available for patients who are unable to take the oral form. UCB has conducted pharmacokinetic studies in normal volunteers and one safety study in epileptic patients using IV levetiracetam. These studies have shown a 1:1 ratio between doses of oral and parental levetiracetam. In addition, several different infusion rates have been studied, from five minutes to fifteen minutes with no significant safety concerns. These studies were performed in adults age 16 and over. This was done because at the time when IV studies were conducted, there was no pediatric approval However, since then a pediatric indication has been approved, based on the results of a successful outpatient pediatric study in children ages four to sixteen years, using levetiracetam as adjunctive therapy for partial seizures.


Study summary:

Each subject will receive open label levetiracetam.


Criteria:

Inclusion Criteria: - Subjects must have a confirmed diagnosis of either partial onset seizures or generalized epilepsy and have received anti-epileptic drug therapy prior to initiation of IV levetiracetam. - Subjects must have a medical condition in which the rapid achievement of serum levels with the use parenteral administration of levetiracetam is desirable. Such as in the case of re-initiating drug therapy to achieve therapeutic serum levels of an inpatient prior to discharge. - Subject may be male or female. - Subject must be four years of age or older, and less than age 23 years. This age is indicative of the patient population typically treated at LeBonheur Children's Medical Center. - Subject or his/her legally authorized representative must sign an informed consent prior to any study-specific procedures. Exclusion Criteria: - Subject has previously participated in any other intravenous levetiracetam study. - Subject has status epilepticus within the last 6 months. - Subject has a history of a drug allergy to levetiracetam. - Subject is pregnant. - Subject has taken an experimental drug within the last 30 days.


NCT ID:

NCT00720863


Primary Contact:

Principal Investigator
James W Wheless, MD
University of Tennessee Healthscience Center Pediatric Neurology


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38103
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.