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.
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.