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A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

NCT05077904•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be ≥12 years of age at the Baseline/Randomization Visit
•Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; 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 has experienced ≥4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit
•Participant has had a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of epilepsy and within the 5 years prior to the Screening Visit, that confirms the absence of a progressive neurological disorder
•Participant is receiving a regimen of antiseizure medications (ASMs) that has been stable (ie, no addition or removal of ASM\[s\]; dose adjustments are permitted to ASM\[s\]; dose adjustments are not permitted for benzodiazepines) for 30 days prior to the Screening Visit
•Male and female participants:
+5 more criteria

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 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 diagnosis of atrial fibrillation or mitral stenosis
•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)
•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 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 upper respiratory tract infection within 4 weeks or bronchitis/pneumonia within 3 months before the Screening Visit
•Participant has a history or presence of acute narrow-angle glaucoma
+15 more criteria

Locations (181)

Ep0162 50506

Phoenix, Arizona, United States

Ep0162 50720

Scottsdale, Arizona, United States

Ep0162 50494

Little Rock, Arkansas, United States

Ep0162 50118

Downey, California, United States

Ep0162 50416

La Jolla, California, United States

Ep0162 50702

Long Beach, California, United States

Ep0162 50505

Los Angeles, California, United States

Ep0162 50492

Orange, California, United States

Ep0162 50722

Poway, California, United States

Ep0162 50716

Sacramento, California, United States

Key Dates

Start Date

December 7, 2021

Primary Completion Date

April 6, 2026

Completion Date

April 6, 2026

Last Updated

March 13, 2026

Enrollment

350

ESTIMATED participants

Conditions

Stereotypical Prolonged Seizures

Interventions

Staccato alprazolam

DRUG

Placebo

OTHER

Contacts

UCB Cares

CONTACT

1-844-599-2273 (USA)UCBCares@ucb.com

UCB Cares

CONTACT

0018445992273 UCBCares@ucb.com