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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.
Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
levetiracetam, levetiracetam, levetiracetam
LeBonheur Children's Medical Center
Le Bonheur Children's Medical Center
Published on BioPortfolio: 2014-07-23T21:21:39-0400
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
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To compare the efficacy and tolerability of levetiracetam (LEV) versus valproate (VPA) monotherapy in adults with genetic generalized tonic-clonic seizures alone (GTCS) and juvenile myoclonic epilepsy...
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Antiepileptic drug (AED) therapy is symptomatic. New AED:s have not decreased the proportion of epilepsy patients resistant to pharmacological treatment. Lamotrigine, levetiracetam and carbamazepine a...
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)
A condition where seizures occur in association with ethanol abuse (ALCOHOLISM) without other identifiable causes. Seizures usually occur within the first 6-48 hours after the cessation of alcohol intake, but may occur during periods of alcohol intoxication. Single generalized tonic-clonic motor seizures are the most common subtype, however, STATUS EPILEPTICUS may occur. (Adams et al., Principles of Neurology, 6th ed, p1174)
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).
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...