RecruitingPHASE3INTERVENTIONAL

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

This study, called "A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures," is a Phase 3 clinical trial. It's for people aged 12 and above who experience predictable, prolonged seizures. The main goal is to test a new nasal spray called Staccato Alprazolam. Researchers want to see if this spray can stop a seizure within 90 seconds and prevent it from returning for up to two hours after treatment, compared to a placebo (a dummy treatment with no active medicine). This research aims to find a fast and effective way to manage these types of seizures in an emergency.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

350

Start

07 Dec 2021

Estimated completion

30 Jun 2026

Stereotypical Prolonged Seizures

What is this study about?

This study is investigating a new treatment called Staccato Alprazolam, which is given as a nasal spray. It's designed for people aged 12 and older who have a specific type of seizure called 'stereotypical prolonged seizures'. This means their seizures are usually quite similar each time and last longer than typical seizures. The study is in Phase 3, which means it's one of the final steps in testing a new medicine before it might be considered for wider use.

The main aim is to see how well this nasal spray works to quickly stop a prolonged seizure. Specifically, researchers are looking to see if it can stop a seizure within 90 seconds and then prevent another seizure from happening for the next two hours. They will compare the effects of the Staccato Alprazolam spray with a 'placebo', which looks like the real medicine but contains no active drug. This helps them understand if any benefits seen are truly from the medicine.

Finding a quick and effective way to stop prolonged seizures is very important. These types of seizures can be distressing and carry risks. If successful, this nasal spray could offer a convenient and rapid treatment option for individuals and their caregivers to use during a seizure emergency.

Key takeaways

Tests a new nasal spray (Staccato Alprazolam) for prolonged seizures.
Aims to stop seizures within 90 seconds and prevent recurrence for 2 hours.
Compares the spray to a 'dummy' treatment (placebo).
Suitable for people aged 12+ with predictable, prolonged seizures.
Requires a dedicated caregiver aged 18+ to help with the study.
Could offer a fast-acting emergency treatment for these seizures.

Who may be eligible?

To join this study, you must be at least 12 years old. You'll also need a caregiver (someone aged 18 or older) who knows you well, looks after you, and can recognise when you're having a seizure. This caregiver could be a family member, partner, friend, or someone who provides daily care.

Your epilepsy must be well-understood, either focal (starting in one part of the brain) or generalised (affecting both sides of the brain), and you must have a clear history of prolonged seizures that follow a similar pattern each time. These types of seizures must have happened at least four times in the last six months, with at least two of those happening in the last three months.

Before the study, you should have had a brain scan (like a CT or MRI) within the last five years that shows there are no ongoing problems with your brain. Also, any anti-seizure medicines you're currently taking must have been stable for at least 30 days before you start the study. Small dose changes to these medicines are allowed, but not for certain types of tranquiliser medicines (benzodiazepines).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 12 years old or older?
Do you have a consistent caregiver over 18 who understands your seizures?
Have you had at least 4 predictable, prolonged seizures in the last 6 months, with 2 in the last 3 months?
Do you have an established epilepsy diagnosis?
Have you had a brain scan (CT or MRI) within the last 5 years that showed no progressive brain conditions?
Have your current anti-seizure medications been stable for at least 30 days (no new meds or stopped meds, but dose tweaks are okay for some)?
Are you able to agree to participate (or does your legal guardian agree for you)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the Staccato Alprazolam nasal spray or a placebo (a dummy spray). You won't know which one you receive. When you experience a prolonged seizure that fits the study criteria, you or your caregiver would use the spray as instructed. Researchers will then observe how quickly the seizure stops and whether another seizure occurs within the next two hours. During the study, you'll have regular visits to check on your health and seizure activity. The total length of your participation in the study would be discussed with you by the research team.

Potential risks and benefits

Taking part in a study like this could potentially offer a faster way to control your prolonged seizures, which might improve your quality of life. However, like any medicine, the nasal spray might cause side effects, and since you might receive a placebo, there's a chance you won't get the active treatment. The research team will explain all known side effects and what to look out for. You should also remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (183)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ep0162 50506
Verified postcode
Phoenix, United States· Recruiting
Ep0162 50720
Verified postcode
Scottsdale, United States· Recruiting
Ep0162 50494
Verified postcode
Little Rock, United States· Recruiting
Ep0162 50118
Verified postcode
Downey, United States· Recruiting
Ep0162 50416
Verified postcode
La Jolla, United States· Recruiting
Ep0162 50702
Verified postcode
Long Beach, United States· Recruiting
Ep0162 50505
Verified postcode
Los Angeles, United States· Withdrawn
Ep0162 50492
Verified postcode
Orange, United States· Completed
Ep0162 50722
Verified postcode
Poway, United States· Recruiting
Ep0162 50716
Verified postcode
Sacramento, United States· Recruiting
Ep0162 50367
Verified postcode
New Haven, United States· Completed
Ep0162 50088
Verified postcode
Washington D.C., United States· Recruiting

Common questions

What is a 'stereotypical prolonged seizure'?

It means a seizure that typically lasts longer than usual and has a similar pattern or symptoms each time it happens.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers see if the real medicine is actually working.

Who is a 'study caregiver'?

This is an adult (18 or over) who knows you well, provides care, and can recognise your seizures. They're important for helping with the study.

Will I know if I'm getting the real medicine or the placebo?

No, in this type of study, neither you nor the research team will know who is getting the active medicine or the placebo. This helps prevent bias in the results.

What does 'Phase 3' mean for a clinical trial?

Phase 3 is usually the final stage of testing a new medicine in a large group of people to confirm its effectiveness and safety before it might be approved for general use.

How to find out more

UCB Cares

ucbcares@ucb.com 1-844-599-2273 (USA) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.