A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
This study is designed to carefully watch the long-term safety and how well people tolerate a medicine called Staccato alprazolam. It's for individuals aged 12 and older who experience prolonged seizures that follow a typical pattern. This medicine is given using a special inhaler. The study aims to see if the medicine continues to be safe and if people can use it without too many problems over a longer period. Importantly, only people who have already used Staccato alprazolam in a previous clinical study are eligible to join this one. This helps researchers understand the medicine's effects over time in individuals already familiar with its use.
At a glance
What is this study about?
This research is looking into a new way to help people who have prolonged seizures, which are seizures that last longer than usual. The medicine being studied is called Staccato alprazolam. It's given using a special inhaler, similar to how asthma medicines are sometimes used. The main goal of this study is to understand its long-term safety and if people can continue to use it without too many unwanted effects. Sometimes, medicines that are safe for short periods need more testing to make sure they are still safe when used for a long time.
This study is building on previous research. It's specifically for people who have already participated in another study where they received Staccato alprazolam. This allows researchers to gather more information on how the medicine affects people further down the line.
By carefully observing participants over an extended period, the researchers希望 (hope) to gather important information that can help doctors understand when and how this medicine might be used safely and effectively to manage prolonged seizures in the future. This kind of research is crucial for developing new treatments and improving the quality of life for people living with epilepsy.
Key takeaways
- This study is for people aged 12 and over with prolonged seizures.
- It's looking at the long-term safety of Staccato alprazolam, given by inhaler.
- You must have used Staccato alprazolam in a previous study to be eligible.
- A main caregiver (18+) is required to help monitor seizures.
- The study involves regular check-ups to monitor your health and seizure activity.
Who may be eligible?
To join this study, you must be at least 12 years old. You'll also need to have an adult caregiver, aged 18 or over, who can recognise and observe your seizures. This caregiver will be an important part of your support during the study.
Participants must have been diagnosed with epilepsy (either focal, generalised, or both) and have a clear history of prolonged seizures that follow a typical pattern. These prolonged seizures must meet specific criteria regarding their length and type. A very important condition for joining this study is that you must have already taken Staccato alprazolam as part of a previous clinical trial.
You cannot join if you have struggled with alcohol or drug use in the past year, or if you are allergic to any part of the study medicine or similar drugs, including certain asthma medicines. You also can't participate if you've had a severe generalised seizure (called convulsive status epilepticus) in the 8 weeks before checking for the study, or if you have seizures that aren't epilepsy-related but look very similar to your epileptic seizures. Finally, if you have severe asthma or a serious sensitivity to things like pollen or animals that cause breathing problems, you would not be able to join.
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 an adult caregiver (18+) who can recognise your seizures?
- Do you have a diagnosis of epilepsy with prolonged seizures that follow a typical pattern?
- Have you previously used Staccato alprazolam in another clinical study?
- Do you have any serious allergies to medicines or severe breathing conditions?
- Have you experienced problems with alcohol or drug use in the last year?
What does participation involve?
If you decide to take part, the researchers will check your health carefully. You'll continue to use Staccato alprazolam, which you've already used in a past study. The study team will regularly monitor your health, how often your seizures happen, and any side effects you might experience. This will involve regular visits to the study clinic for assessments. The exact number of visits, what happens at each visit, and the total length of your participation will be explained in detail by the study team, as it can vary.
Potential risks and benefits
Locations (146)
- Ep0165 50506Verified postcodePhoenix, United States
- Ep0165 50720Verified postcodeScottsdale, United States
- Ep0165 50494Verified postcodeLittle Rock, United States
- Ep0165 50118Verified postcodeDowney, United States
- Ep0165 50416Verified postcodeLa Jolla, United States
- Ep0165 50702Verified postcodeLong Beach, United States
- Ep0165 50722Verified postcodePoway, United States
- Ep0165 50716Verified postcodeSacramento, United States
- Ep0165 50367Verified postcodeNew Haven, United States
- Ep0165 50088Verified postcodeWashington D.C., United States
- Ep0165 50721Verified postcodeBoca Raton, United States
- Ep0165 50515Verified postcodeGulf Breeze, United States
Common questions
What is Staccato alprazolam?
It's a medicine given through an inhaler, similar to an asthma puffer, being studied for prolonged seizures.
Who can join this study?
People aged 12 and over who have epilepsy, prolonged seizures, and have already used Staccato alprazolam in a previous study.
Why do I need a caregiver?
An adult caregiver (18+) is needed to help recognise and observe your seizures as part of the study.
What kind of seizures does this study focus on?
It focuses on prolonged seizures that follow a typical pattern, including focal, generalised, or combinations that last a certain amount of time.
Can I stop participating in the study at any time?
Yes, you have the right to withdraw from the study at any point without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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