NCT05077904 · UCB Biopharma SRL
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
What this study is about
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 experimental medicinal product (IMP) administration.
View original scientific description
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.
Interventions
DRUG
Staccato alprazolam
Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
OTHER
Placebo
Route of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.
Primary outcome measures
Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration
Time frame: From start of IMP treatment through 6 hours
Treatment success for the treated seizure is defined as termination of the seizure within 90 seconds after IMP administration.
Treatment success for the treated seizure with no recurrence up to 2 hours
Time frame: From start of IMP treatment through 2 hours
Treatment success for the treated seizure is defined as termination of the treated seizure within 90 seconds after IMP administration and no recurrence of seizure(s) from IMP administration to 2 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 2 hours after IMP administration.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Little Rock, Arkansas
- Downey, California
- La Jolla, California
- Long Beach, California
- Los Angeles, California
- Orange, California
- Poway, California
- Sacramento, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
And 41 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations