The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
Participant must be ≥12 years of age at the Baseline/Randomization Visit
Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; the study caregiver(s) must be able to recognize and observe the participant's seizures
Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
Episodes of a focal seizure with a minimum duration of 3 minutes
Participant has a current history of alcohol or drug use disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year
Participant has a known hypersensitivity to any components of the IMP or comparable drugs (and/or an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specific requirements)
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
Parallel
Staccato alprazolam
DrugRoute of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
Placebo
Other interventionRoute of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.
Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration
Treatment success for the treated seizure is defined as termination of the seizure within 90 seconds after IMP administration.
Treatment success for the treated seizure with no recurrence up to 2 hours
Treatment success for the treated seizure is defined as termination of the treated seizure within 90 seconds after IMP administration and no recurrence of seizure(s) from IMP administration to 2 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 2 hours after IMP administration.
Treatment success for treated seizure with no recurrence after 4 hours
Treatment success defined as termination of the treated seizure within 90 seconds after IMP administration, with no recurrence of seizure(s) up to 4 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 4 hours after IMP administration.
Treatment success for treated seizure with no recurrence after 6 hours
Treatment success defined as termination of the treated seizure within 90 seconds after IMP administration, with no recurrence of seizure(s) up to 6 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 6 hours after IMP administration.
Time from IMP administration to cessation of the treated seizure
The time will be assessed from IMP administration to cessation of the treated seizure (taking administration of seizure rescue treatment as censoring point).
Frequency of respiratory treatment emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
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