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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
Route 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.
Time frame: From start of IMP treatment through 6 hours
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.
Time frame: From start of IMP treatment through 2 hours
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.
Time frame: From start of IMP treatment through 4 hours
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 frame: From start of IMP treatment through 6 hours
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).
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Time frame: From start of IMP treatment through 6 hours
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.
Time frame: From start of IMP treatment up to the Safety Follow-up Visit (Week 19)
Number of subsequent seizure(s) up to 2 hours after IMP administration
The number of subsequent seizure(s) will be assessed up to 2 hours after IMP administration.
Time frame: From start of IMP treatment through 2 hours
Time to first subsequent seizure up to 2 hours after IMP administration
The time to first subsequent seizure will be assessed up to 2 hours after IMP administration and is defined as time from end of IMP treated seizure to start of first subsequent seizure.
Time frame: From start of IMP treatment through 2 hours