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The purpose of this study is to demonstrate the efficacy and safety of Vanquix for the management of acute repetitive seizures (ARS)
This study will provide clinical evidence for the effective and safe use of a diazepam auto-injector, Vanquix, to provide patients and their caregivers with an alternative to rectal administration.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
University of Chicago
Published on BioPortfolio: 2014-08-27T03:15:30-0400
This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study involving adolescents and adults with refractory (drug-resistant) epilepsy
Benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in children. It is known to be age-dependent and presumably genetic. Age of onset ranges from one to f...
This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBSF) is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in c...
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 hypothesis of the study is that DBSF will be safe and tolerable in pediatric patients during the Interictal state (Period A) and the ictal/peri-ictal state (Period B) of Epilepsy, and ...
No study has evaluated the cardiovascular effects of diazepam in elderly subjects that assume diazepam to induce sleep.
About 20 per 100,000 children have convulsive status epilepticus every year, a life-threatening condition. Benzodiazepines are the first-line treatment for prolonged and recurrent seizures. Our study ...
The objective of this study was to assess for independent association of anxiety symptoms with epilepsy localization and other epilepsy-related and demographic factors in a large tertiary care adult e...
Diazepam is labeled for status epilepticus (SE) in children, but there are limited data characterizing its disposition in pediatric patients. We developed a population pharmacokinetic (PK) model of i....
Cardiovascular comorbidities of epilepsy such as hypertension, hyperlipidemia, and diabetes are associated with myocardial infarction (MI). Little data on the development of subsequent cardiovascular ...
An intermediate in the metabolism of DIAZEPAM to OXAZEPAM. It may have actions similar to those of diazepam.
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.
A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)
An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...
Epilepsy is defined as a disorder of brain function characterized by recurrent seizures that have a sudden onset. (Oxford Medical Dictionary). A seizure is caused by a sudden burst of excess electrical activity in the brain, causing a tempora...