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.

Inclusion Criteria:

Inclusion Criteria for Patient:

- Clinical diagnosis of epilepsy, on a stable antiepileptic drug (AED) regimen for at
least 2 weeks, and requires intermittent medical intervention to control episodes of
acute repetitive seizures (ARS)

- Experienced at least 2 episodes of ARS in previous year, one of which occurred in
previous 6 months

- Has episodes of ARS that include complex partial or generalized seizures

- Has a responsible caregiver available to participate

- Is not pregnant and not lactating and is practicing an acceptable method of birth
control

Inclusion Criteria for Caregiver(s):

- Is 18 years of age or older and is responsible

- Is available to accompany the patient to clinic visits

Exclusion Criteria:

- Petit mal status or petit mal variant status

- History of ARS consistently progressing to status epilepticus

- Has history of failure to respond to benzodiazepine treatment

- Hypersensitive to diazepam

- Acute narrow angle glaucoma

- Abuses alcohol and/or other substances

- Took another investigational drug in previous 30 days

- Acute or progressive neurological disease, severe psychiatric disease, or severe
mental abnormality