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Clinical Trials in the UK / NCT05076617
Enrolling by invitation Phase 3

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

NCT05076617 · tracked via the Priya Life Science UK tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2022-02-03
Last updated
2026-08-14

Condition(s) studied

Stereotypical Prolonged Seizures

Investigational drug(s) / intervention(s)

Staccato alprazolam

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)

Trial sites (137)

FacilityCityRegionStatus
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.

More UCB Biopharma SRL trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT05076617 on ClinicalTrials.gov ↗ ← All trials in the UK