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Safety Study Of Intravenous Levetiracetam

2014-07-23 21:21:39 | BioPortfolio

Summary

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 Design

Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Seizures

Intervention

levetiracetam, levetiracetam, levetiracetam

Location

LeBonheur Children's Medical Center
Memphis
Tennessee
United States
38103

Status

Completed

Source

Le Bonheur Children's Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:21:39-0400

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Medical and Biotech [MESH] Definitions

An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.

Seizures that occur during a febrile episode. It is a common condition, affecting 2-5% of children aged 3 months to five years. An autosomal dominant pattern of inheritance has been identified in some families. The majority are simple febrile seizures (generally defined as generalized onset, single seizures with a duration of less than 30 minutes). Complex febrile seizures are characterized by focal onset, duration greater than 30 minutes, and/or more than one seizure in a 24 hour period. The likelihood of developing epilepsy (i.e., a nonfebrile seizure disorder) following simple febrile seizures is low. Complex febrile seizures are associated with a moderately increased incidence of epilepsy. (From Menkes, Textbook of Child Neurology, 5th ed, p784)

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An anticonvulsant especially useful in the treatment of absence seizures unaccompanied by other types of seizures.

A disorder characterized by recurrent focal onset seizures which have sensory (i.e., olfactory, visual, tactile, gustatory, or auditory) manifestations. Partial seizures that feature alterations of consciousness are referred to as complex partial seizures (EPILEPSY, COMPLEX PARTIAL).

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