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

• Seizures
• Epilepsies, Partial
• Epilepsy, Complex Partial
• Epilepsy, Generalized
• Epilepsy

• Drug: Placebo
  Intramuscular autoinjector; administered at onset of an episode
• Drug: Vanquix Auto-Injector (Diazepam Injection)
  Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode

• Placebo Comparator: Placebo
  During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
  Intervention: Drug: Placebo
• Experimental: Diazepam
  During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
  Intervention: Drug: Vanquix Auto-Injector (Diazepam Injection)

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.