• Time to next seizure or rescue [ Time Frame: Beginning at least 15 minutes after and within 12 hours of study drug administration ] [ Designated as safety issue: No ]
  

In the United States, more than 2 million people have epilepsy. Most patients with epilepsy are able to control their seizures with drugs and/or surgery. However, many patients (400,000 to greater than 600,000) are considered refractory to antiepileptic drugs and still experience acute repetitive seizures (ARS). 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. Vanquix™ (diazepam autoinjector) also contains diazepam, but is administered by an automated injectable device into the leg muscle. Vanquix™ 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 Vanquix™ compared to placebo for treating ARS.