Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.
To evaluate the efficacy and safety of Vanquix for the management of selected, refractory, patients with epilepsy who require intermittent medical intervention provided by caregivers who are not health care professionals, and who are not under the direct supervision of a healthcare professional at the time of administration to control episodes of acute repetitive seizures (ARS).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Placebo, Vanquix Auto-Injector (Diazepam Injection)
Pfizer Investigational Site
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00319501
- Information obtained from ClinicalTrials.gov on May 19, 2013
Medical and Biotech [MESH] Definitions
An intermediate in the metabolism of DIAZEPAM to OXAZEPAM. It may have actions similar to those of diazepam.
Diazepam Binding Inhibitor
An 86-amino acid polypeptide, found in central and peripheral tissues, that displaces diazepam from the benzodiazepine recognition site on the gamma-aminobutyric acid receptor (RECEPTORS, GABA). It also binds medium- and long-chain acyl-CoA esters and serves as an acyl-CoA transporter. This peptide regulates lipid metabolism.
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)
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)
The purpose of this study is to demonstrate the efficacy and safety of Vanquix for the management of acute repetitive seizures (ARS)
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack. The study could take appr...
The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by untrained...
The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure...
The primary purpose of this study is to determine the ability of the Protector Cap Jet Injector to prevent cross-contamination in the next injection sample. The hypothesis is that the Pro...
To cite this article: Frew A.J. What are the 'ideal' features of an adrenaline (epinephrine) auto-injector in the treatment of anaphylaxis? Allergy 2010; DOI: 10.1111/j.1398-9995.2010.02450.x. Abstrac...
The optimal time for transferring responsibilities for anaphylaxis recognition and epinephrine auto-injector use from adults to children and teenagers has not yet been defined.
A rapid and sensitive flow-injection chemiluminescence (FI-CL) method is described for the determination of diazepam based on its reaction with N-bromosuccinimide (NBS) in alkaline medium in the prese...
A detailed description for the do-it-yourself construction of a high-performance thermodesorption GC injector (HPTI) is presented. The injector consists of a heated desorption chamber, a cooled loop f...
Objective-To evaluate the pharmacokinetics of diazepam administered per rectum via compounded (ie, not commercially available) suppositories and determine whether a dose of 2 mg/kg in this formulation...