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NCT05076617

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
PHASE3Ages 12+InterventionalTreatment
UCB Biopharma SRL
~300 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Staccato alprazolam

At a glance

Recruiting sites
0 of 140 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of treatment-emergent adverse events (TEAEs)
Measured over From Baseline up to the End of Study Visit (up to 78 months)
+2 more outcomes measured

Conditions

Stereotypical Prolonged Seizures

Explore related trials

Stereotypical Prolonged Seizures

Where it's being run

140 sites across 32 states
China25
Japan19
Florida8
Spain8
Poland7
New York6
Germany6
California5

Study leadership

  • UCB Cares · STUDY_DIRECTOR · 001 844 599 2273 (UCB)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))

Exclusion

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

What this trial measures

  • 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 studyFrom 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 TEAEsFrom 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