Study the Efficacy and Safety of Diazepam Auto-injector for Controled Episodes of Acute Repetitive Seizures
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | March 2008 |
| End Date: | December 2011 |
| Contact: | Michael Kohrman, MD |
| Email: | mkohrman@peds.bsd.uchicago.edu |
| Phone: | 773-702-4786 |
Phase 3 Randomized, Dlouble-Blind, Parallel, Placebo-Controlled, Multicenter Study, With Optional Open-Label Continuation, of the Efficacy and Safety of Vanquix Auto-Injector (Diazepam Injection) for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Medical Intervention to Control Episodes of Acute Repetitive Seizures
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.
Inclusion Criteria:
- patients >2 years of age non-pregnant and not lactating epilepsy diagnosis ARS that
includes partial/generalized seizures >2 episodes of repetitive seizures sufficient
muscle mass for thigh injection responsible caregiver who can recognize ARS episode
Exclusion Criteria:
- >2 - <5 years of age history of consistent progression from ARS to status epilepticus
history of benzodiazepine treatment failure hypersensitivity to diazepam acute narrow
angle glaucoma
We found this trial at
1
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