Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

Key Inclusion Criteria

For Patient:

• Older than 2 years of age and between 6 and 136 kg body weight

• Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring 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 or lactating and is practicing an acceptable method of birth control.

For Caregiver:

• Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:

• Recognize an episode of repetitive seizures for which the injection was intended,

• Administer study drug

• Count and record seizures and respiratory rate in the patient diary,

• Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment

• Recognize the need for immediate medical attention.

Key Exclusion Criteria

For Patient:

• Petit mal status or petit mal variant status

• History of ARS consistently progressing to status epilepticus

• History of failure to respond to benzodiazepine treatment

• Hypersensitivity to diazepam

• Acute narrow angle glaucoma

• Alcohol and/or other substance abuse

• Has taken another investigational drug in previous 30 days

• Acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.