The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
* Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period.
Frequency of treatment-emergent adverse events (TEAEs)
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
Frequency of TEAEs leading to withdrawal from study
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
Frequency of serious TEAEs
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
A responder after up to a maximum of 10 treated seizures will be defined as having a termination of seizure within 90 seconds after IMP dministration.
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Downey, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
Ep0165 50722
Poway, California, United States
Ep0165 50716
Sacramento, California, United States
Ep0165 50367
New Haven, Connecticut, United States
Ep0165 50088
Washington D.C., District of Columbia, United States
...and 135 more locations
Time frame: From start of IMP treatment up to 12 months
Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
A responder after up to a maximum of 10 treated seizures will be defined as termination of 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 up to 12 months
Frequency of respiratory TEAEs
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Time frame: From Baseline up to the End of Study Visit (up to 78 months)