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Staccato Alprazolam for Epilepsy
Study Summary
This trial tests if Staccato Alprazolam is more successful than placebo in terminating a seizure within 90 seconds and preventing recurrence for 2 hours.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your liver enzymes or total bilirubin levels are higher than they should be.I have a caregiver over 18 who can observe and recognize my seizures.My recent brain scans show no progressive neurological disorder.I have seizures that can't be told apart from epileptic ones.I am not pregnant, not breastfeeding, and follow specific birth control measures.I agree to use birth control and not donate sperm for 7 days after treatment.I had a cold or similar illness in the last 4 weeks or a lung infection in the last 3 months.I am not allergic to the trial medication or similar drugs, including albuterol.I have been diagnosed with atrial fibrillation or mitral stenosis.I have been using VNS for less than 6 months or my VNS settings were changed recently.I am 12 years old or older.I have had a major seizure episode within the last 8 weeks.I regularly use opioids or sedatives.I tested positive for COVID-19 and needed treatment for severe symptoms.I have or had acute narrow-angle glaucoma.I have been using benzodiazepines regularly for the last week.I can sign the consent form and follow the study's rules.Your oxygen level is below 95% for more than 30 seconds during the screening visit.My liver condition is currently unstable.Your electrocardiogram (ECG) shows abnormal results.You have a significant abnormality in your lab test results that could make it risky for you to be in the study or could make it hard to understand the study results.I have severe allergies or breathing problems.My seizure medication dose has been the same for the last 30 days.I have or my family has a history of long QT syndrome or sudden unexplained fainting.I am on medication for a major psychiatric disorder and expect changes to it during the study.I have a serious lung condition that is not mild asthma.You tested positive for drugs in your urine at the screening visit.I cannot take alprazolam due to my health condition.I am currently taking medication that strongly affects liver enzyme CYP3A4.Your blood pressure or heart rate is not within the normal range after resting for 5 minutes.I have been diagnosed with epilepsy and have a history of long-lasting seizures.I've had 4 or more long seizures in the last 6 months, with 2 happening in the last 3 months.You have had problems with alcohol or drugs in the past year.I am regularly taking medication that affects my heart and blood pressure.
- Group 1: Staccato alprazolam Arm
- Group 2: Placebo Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the FDA's most recent thoughts on Staccato alprazolam?
"There is some evidence backing up Staccato alprazolam's efficacy, as well as numerous reports testifying to its safety. As such, our team at Power has given it a 3."
In how many different medical clinics is this study being run today?
"Data indicates that this trial has 31 active sites, including Ep0162 50299 in New Brunswick, Ep0162 50298 in New york, and Ep0162 50517 in New Orleans."
What is the efficacy of Staccato alprazolam in other medical studies?
"Staccato alprazolam was first investigated in 40676. So far, there have been 18336 completed clinical trials and 3 ongoing studies. Most of these are happening near New Brunswick, New jersey."
How many people are being treated with the experimental medication in this research project?
"250 research subjects that meet the study's inclusion criteria are necessary to run this clinical trial. UCB Biopharma SRL is sponsoring the medical trial and it will be conducted at various sites, such as Ep0162 50299 in New Brunswick, New jersey and Ep0162 50298 in metropolitan New york City."
Are new participants still being sought for this experiment?
"The clinical trial is currently looking for participants and has admitted 250 patients between 31 sites, as stated on clinicaltrials.gov. The study was first posted on December 7th, 2021 and edited most recently on November 9th, 2022."
What other similar research projects exist for comparison?
"Staccato alprazolam has been under clinical investigation since 2021. After the first Phase 1 trial, which was carried out in 250 people and sponsored by UCB Biopharma SRL, Staccato Alprazolam received its drug approval for Phase 3 trials. To date, there are 3 ongoing studies involving Staccato Alprazolam being conducted across 28 cities and 10 countries."
What is the purpose of this clinical trial?
"The goal of this study is to measure the treatment success for the treated seizure with no recurrence up to 2 hours. Secondary outcomes include time to first subsequent seizure up to 2 hours after IMP administration, which is defined as time from end of IMP treated seizure to start of first subsequent seizure., Treatment success for treated seizure with no recurrence after 4 hours, which is defined as termination of the treated seizure within 90 seconds after IMP administration, with no recurrence of seizure(s) up to 4 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 4 hours after IMP administration., and Time from IMP administration to"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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