A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Staccato alprazolam: * Pharmaceutical form: Inhalation powder
* Route of administration: Inhalation
Participants will receive Staccato alprazolam during the Treatment Period.
Study summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* Participant must be ≥12 years of age at the time of signing informed consent
* Participant must have a study caregiver ≥18 years of age at the time of signing the informed consent; the study caregiver(s) must be able to recognize and observe the participant's seizures
* Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following:
1. Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
2. Episodes of a focal seizure with a minimum duration of 3 minutes
3. 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
* Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))
Exclusion Criteria:
* 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 investigational medicinal product (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 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
* Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation). NOTE: Participants with mild asthma who qualify for inclusion in the are allowed to be enrolled even though they have known airway hypersensitivity
* Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases \[including idiopathic pulmonary fibrosis\]) and/or recent history or presence of hemoptysis or pneumothorax
* Participant has had a positive antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs/symptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and/or oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to Screening
* Participant has experienced a severe upper respiratory tract infection within 4 weeks or severe bronchitis/pneumonia within 3 months before the Screening Visit
* Participant has a history or presence of acute narrow-angle glaucoma
* Participant has a condition for which oral alprazolam is contraindicated as per the regional labeling
* Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone
* Participant is taking any opioids or sedative hypnotics on a chronic basis
* Participant is taking nonselective beta blockers on a chronic basis
Primary outcome measure(s)
Frequency of treatment-emergent adverse events (TEAEs) — From Baseline up to the End of Study Visit (up to 78 months) 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.
Frequency of TEAEs leading to withdrawal from study — From Baseline up to the End of Study Visit (up to 78 months) 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.
Frequency of serious TEAEs — From Baseline up to the End of Study Visit (up to 78 months) 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
Trial sites (137)
Facility
City
Region
Status
Ep0165 50506
Phoenix
Arizona
Ep0165 50720
Scottsdale
Arizona
Ep0165 50494
Little Rock
Arkansas
Ep0165 50118
Downey
California
Ep0165 50416
La Jolla
California
Ep0165 50702
Long Beach
California
Ep0165 50722
Poway
California
Ep0165 50716
Sacramento
California
Ep0165 50088
Washington D.C.
District of Columbia
Ep0165 50515
Gulf Breeze
Florida
Ep0165 50508
Jacksonville
Florida
Ep0165 50342
Jacksonville
Florida
Ep0165 50199
Miami
Florida
Ep0165 50676
Miami
Florida
Ep0165 50509
Orlando
Florida
Ep0165 50703
Rockledge
Florida
Ep0165 50308
Tampa
Florida
Ep0165 50323
Honolulu
Hawaii
Ep0165 50512
Boise
Idaho
Ep0165 50493
Chicago
Illinois
Ep0165 50504
Fort Wayne
Indiana
Ep0165 50517
New Orleans
Louisiana
Ep0165 50615
Boston
Massachusetts
Ep0165 50047
Boston
Massachusetts
Ep0165 50507
St Louis
Missouri
Ep0165 50299
New Brunswick
New Jersey
Ep0165 50497
Amherst
New York
Ep0165 50625
New Hyde Park
New York
Ep0165 50298
New York
New York
Ep0165 50490
New York
New York
Ep0165 50518
New York
New York
Ep0165 50034
Rochester
New York
Ep0165 50514
Charlotte
North Carolina
Ep0165 50715
Durham
North Carolina
Ep0165 50701
Portland
Oregon
Ep0165 50096
Philadelphia
Pennsylvania
Ep0165 50364
Philadelphia
Pennsylvania
Ep0165 50089
Philadelphia
Pennsylvania
Ep0165 50511
Pittsburgh
Pennsylvania
Ep0165 50491
Pittsburgh
Pennsylvania
+ 97 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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