A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Enrolling by invitation · Phase 3

Conditions studied: Stereotypical Prolonged Seizures

In brief

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

Key facts

Study ID

NCT05076617

Run by

UCB Biopharma SRL

People needed

300

Starts

2022-02-03

Expected to finish

2028-11-30

Last updated by the study team

2026-07-31

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• 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))

You may not qualify if…

• 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

Where it is running

• Ep0165 50720 — Scottsdale, Arizona, United States
• Ep0165 50494 — Little Rock, Arkansas, United States
• Ep0165 50118 — Downey, California, United States
• Ep0165 50416 — La Jolla, California, United States
• Ep0165 50702 — Long Beach, California, United States
• Ep0165 50722 — Poway, California, United States
• Ep0165 50716 — Sacramento, California, United States
• Ep0165 50088 — Washington D.C., District of Columbia, United States
• Ep0165 50515 — Gulf Breeze, Florida, United States
• Ep0165 50508 — Jacksonville, Florida, United States
• Ep0165 50342 — Jacksonville, Florida, United States
• Ep0165 50199 — Miami, Florida, United States
• Ep0165 50676 — Miami, Florida, United States
• Ep0165 50509 — Orlando, Florida, United States
• Ep0165 50703 — Rockledge, Florida, United States
• Ep0165 50308 — Tampa, Florida, United States
• Ep0165 50323 — Honolulu, Hawaii, United States
• Ep0165 50512 — Boise, Idaho, United States
• Ep0165 50493 — Chicago, Illinois, United States
• Ep0165 50375 — Springfield, Illinois, United States
• Ep0165 50504 — Fort Wayne, Indiana, United States
• Ep0165 50517 — New Orleans, Louisiana, United States
• Ep0165 50615 — Boston, Massachusetts, United States
• Ep0165 50047 — Boston, Massachusetts, United States
• Ep0165 50506 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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