A clinical research study for people who experience prolonged epileptic seizures

Seizure emergencies involving prolonged seizures are unlikely to stop without treatment, may become more difficult to control with time, and may lead to significant morbidity and mortality. This confirmatory study (EP0162) will investigate the efficacy and safety of a single administration of Staccato alprazolam in an outpatient setting in study participants 12 years of age and older who experience a qualifying seizure event. A qualifying seizure event is a stereotypical prolonged seizure that meets any of the following criteria:

a) Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes

b) Episodes of a focal seizure with a minimum duration of 3 minutes

c) Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes.

Inclusion criteria:

- Are 12 years of age or older
- Have focal or generalized epilepsy, or a combination of the two
- Have experienced at least 2 prolonged seizures within the past 3 months
- Have an adult who can act as a study partner to assist you throughout the study

Exclusion criteria:

- Participant has a diagnosis of atrial fibrillation or mitral stenosis.
- Participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8 weeks prior to the Screening Visit.
- Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures.