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Study on the Safety and Effectiveness of Alprazolam for Treating Long Seizures in Patients Aged 12 and Older

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a treatment for people aged 12 and older who experience stereotypical prolonged seizures. These are types of seizures that last longer than usual and can be part of conditions like epilepsy. The treatment being tested is called Staccato Alprazolam, which is a special form of the medication alprazolam. It is delivered through a handheld device that allows the medicine to be inhaled as a powder. This study will compare the effects of Staccato Alprazolam with a placebo to see how well it can stop a seizure quickly and prevent another one from happening soon after.

The main goal of the study is to determine if a single dose of Staccato Alprazolam can stop a seizure within 90 seconds and prevent any more seizures for up to two hours. Participants will be randomly assigned to receive either the Staccato Alprazolam or a placebo. The study will take place over a period of time, during which participants will be monitored to see how they respond to the treatment. The study will also look at how long it takes for the seizure to stop after taking the medication and whether there are any side effects related to breathing.

Participants will be involved in the study as outpatients, meaning they will not need to stay in a hospital. The study aims to provide valuable information on whether Staccato Alprazolam is a safe and effective option for treating long seizures in both children and adults. The results could help improve treatment options for those who experience these types of seizures.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must be at least 12 years old and have a caregiver who is at least 18 years old. The caregiver should be able to recognize and observe the participant's seizures.

    The participant should have a history of prolonged seizures and must have experienced at least four episodes in the past six months, with the last two episodes occurring within three months before joining the study.

  2. Step 2

    Treatment administration

    The participant will receive a single administration of Staccato alprazolam or a placebo. The medication is in the form of an inhalation powder, pre-dispensed for use.

    The objective is to rapidly stop a seizure episode within 90 seconds and prevent any recurrence for up to two hours after administration.

  3. Step 3

    Monitoring period

    The participant will be monitored for treatment success, defined as no recurrence of the treated seizure after two hours.

    Secondary outcomes include no recurrence after four and six hours, the time taken for the seizure to stop after administration, and the frequency of any respiratory side effects.

  4. Step 4

    Follow-up

    The participant will be observed for any subsequent seizures up to two hours after the medication is given.

    The time to the first subsequent seizure, if any, will also be recorded.

Who can join the trial?

12 criteria

  • The participant must be at least 12 years old at the start of the study.
  • The participant must have a caregiver who is at least 18 years old. This caregiver can be a family member, friend, or someone who takes care of the participant daily and knows how to recognize and observe the participant's seizures.
  • The participant must have a confirmed diagnosis of epilepsy, which is a condition that causes seizures. The participant should have a history of specific types of prolonged seizures, such as:
    • Generalized seizures that start with a series of absence or myoclonic seizures lasting at least 5 minutes.
    • Focal seizures lasting at least 3 minutes.
    • Focal seizures or a series of myoclonic seizures lasting at least 90 seconds, followed by a generalized seizure lasting at least 3 minutes.
    • Before joining the study, the participant must have had at least 4 episodes of prolonged seizures in the past 6 months, with the last 2 episodes occurring within 3 months before the study starts.
    • The participant must have had a brain scan, such as a CT or MRI, within the last 5 years that shows no progressive brain disorder.
    • The participant must be on a stable treatment plan with anti-seizure medications for at least 30 days before the study starts. This means no new medications have been added or removed, although dose adjustments are allowed, except for certain medications called benzodiazepines.
    • Both male and female participants must agree to use birth control during the study and for a short period after receiving the study medication. Male participants must also agree not to donate sperm during this time.
    • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for 30 days after receiving the study medication.
    • The participant must be able to understand and sign a consent form, agreeing to follow the study's rules and requirements. If the participant is a minor, they must provide assent, which is a form of agreement suitable for their age.
    • The participant's caregiver must also be able to understand and sign a consent form, agreeing to follow the study's rules and requirements.

Who cannot join the trial?

4 criteria

  • Patients who have a medical condition other than a stereotypical prolonged seizure may not be eligible. A stereotypical prolonged seizure is a type of seizure that lasts longer than usual and follows a predictable pattern.
  • Patients who are not within the specified age range for the study may be excluded. The age range includes children, adolescents, and adults.
  • Both male and female patients are considered for the study, but certain conditions specific to gender may lead to exclusion.
  • Patients who are part of a vulnerable population, which means they may have additional health or social challenges, might not be eligible.
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Investigated drugs

Staccato Alprazolam is a medication being studied for its ability to quickly stop prolonged seizures in individuals aged 12 and older. It is designed to be administered in a way that allows it to act rapidly, with the goal of ending a seizure episode within 90 seconds and preventing any further seizures for up to 2 hours after taking the medication.

What is already known about the treatment

Staccato Alprazolam – This medication is administered through inhalation using a specialized device, allowing for rapid delivery into the bloodstream. It is currently being studied in clinical trials for its effectiveness in treating stereotypical prolonged seizures. The main therapeutic indication is to quickly stop seizure episodes and prevent their recurrence shortly after administration. At the molecular level, alprazolam works by enhancing the effects of a neurotransmitter called GABA, which helps calm the nervous system. It is classified as a benzodiazepine, a group of medications known for their sedative and anti-anxiety properties.

Investigated diseases

Stereotypical Prolonged Seizure – This condition involves seizures that last longer than usual, often exceeding five minutes, and can be difficult to stop without medical intervention. These seizures are characterized by repetitive, stereotyped movements or behaviors that are consistent with previous episodes experienced by the individual. During a prolonged seizure, the person may lose consciousness, experience muscle stiffness, or have jerking movements. The condition can occur in individuals with epilepsy or other neurological disorders. It is important to monitor the duration and frequency of these seizures, as they can lead to further complications if not managed properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510950-29-00Protocol codeEP0162Estimated enrolment350 patientsSponsorUCB Biopharma

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).