A Phase III, Randomized Double-Blind, Parallel, Placebo-Controlled, Multicenter Study, With Optional Open-Label Continuation, of the Safety and Efficacy of VanquixTM 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
Project Description: An ARS is an episode of multiple seizures that differs from the patient’s usual seizure pattern and is often recognizable by the patient’s family and caregivers. The ARS is usually described as a bout or cluster of seizures that occurs over a short period of time in which the patient regains consciousness in between seizures. Only one drug is currently available that persons other than health care professionals (e.g., patient’s caregiver) may give to control ARS. This drug is called Diastat®. Diastat® is a diazepam rectal gel and, although it is effective, it may be difficult, inconvenient, or objectionable to use because of its rectal administration. VanquixTM (diazepam autoinjector) also contains diazepam, but is administered by an automated injectable device into the leg muscle. VanquixTM may be less difficult and more convenient to use by caregivers, however, its effectiveness and safety have not been studied in patients. This study will determine the effectiveness and safety of VanquixTM compared to placebo for treating ARS.
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