Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions
Summary
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fed conditions
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Seizures
Intervention
Levetiracetam
Location
Novum Pharmaceutical Research Services
Houston
Texas
United States
77042
Status
Completed
Source
Roxane Laboratories
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00827320
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Clonazepam
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, Febrile
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)
Alcohol Withdrawal Seizures
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)
Ethosuximide
An anticonvulsant especially useful in the treatment of absence seizures unaccompanied by other types of seizures.
Epilepsy, Partial, Sensory
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).
Clinical Trials
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
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.
The purpose of this study is to determine the correct dosing for intravenous levetiracetam in term new born babies with seizures. In addition information on safety and efficacy will be col...
Safety Study Of Intravenous Levetiracetam
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 disor...
Prevention of Post-traumatic Seizures With Levetiracetam
Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and l...
Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset s...
PubMed Articles
AIMS: The mechanisms underlying the changes in blood-brain barrier (BBB) integrity and the generation of seizures in childhood associated with preexisting brain lesions like cortical dysplasia (CD) ar...
Levetiracetam (LEV) is known to inhibit convulsive seizures and is clinically used for treating both partial and generalized seizures. The study was performed to determine whether LEV possesses an inh...
Several new antiepileptic drugs (AEDs) have been introduced for clinical use recently. These new AEDs, like the classic AEDs, target multiple cellular sites both pre- and postsynaptically. The use of...
Abstract Objective: Some patients with epilepsy require treatment with >1 adjunctive antiepileptic drug (AED) to achieve adequate seizure remission. The purpose of this analysis was to evaluate the ef...
A case of levetiracetam-induced thrombocytopenia.
Rare cases of levetiracetam-induced thrombocytopenia have been reported in the literature. We report a case of glioblastoma multiforme and partial epilepsy treated with levetiracetam with subsequent d...
