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Benzodiazepine
Staccato Alprazolam for Seizures
Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to the end of study visit (up to 48 months)
Awards & highlights
Study Summary
This trial will study the effects of taking Staccato alprazolam over a long period of time.
Who is the study for?
This trial is for people aged 12 and older with focal or generalized epilepsy who have had prolonged seizures. They must have a caregiver to monitor them, no recent severe respiratory issues, no drug abuse in the past year, not be allergic to alprazolam or similar drugs, and should not take certain medications like strong CYP3A4 inhibitors.Check my eligibility
What is being tested?
The study tests Staccato alprazolam's long-term safety and tolerability in patients with epilepsy experiencing prolonged seizures. Participants previously involved in specific Staccato alprazolam studies are eligible.See study design
What are the potential side effects?
While the side effects of Staccato alprazolam aren't detailed here, common ones may include drowsiness, coordination problems, fatigue, and potential respiratory issues given its relation to alprazolam.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with epilepsy and have a history of long-lasting seizures.
Select...
I have completed a study with Staccato alprazolam.
Select...
I am 12 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to the end of study visit (up to 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to the end of study visit (up to 48 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of TEAEs leading to withdrawal from study
Frequency of serious TEAEs
Frequency of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Frequency of respiratory TEAEs
Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
Trial Design
1Treatment groups
Experimental Treatment
Group I: Staccato alprazolamExperimental Treatment1 Intervention
Participants will receive Staccato alprazolam by inhalation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Staccato alprazolam
2022
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,136 Total Patients Enrolled
15 Trials studying Epilepsy
2,470 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,663 Total Patients Enrolled
50 Trials studying Epilepsy
11,854 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had acute narrow-angle glaucoma.I have mild asthma or other allergies affecting my breathing but can still participate.I have had a major seizure episode in the last 8 weeks.I regularly take opioids or sedatives.I am not allergic to the trial medication or similar drugs, including albuterol.I tested positive for COVID-19 and needed treatment for breathing problems.I have a serious lung condition other than mild asthma, or I've recently coughed up blood or had a collapsed lung.I am regularly taking medication that affects my heart and blood pressure.I had a severe cold or flu in the last 4 weeks or serious lung infection in the last 3 months.I am currently taking medication that strongly affects liver enzyme activity.I have seizures that might not be due to epilepsy.I have been diagnosed with epilepsy and have a history of long-lasting seizures.I have completed a study with Staccato alprazolam.You have had problems with alcohol or drug use in the past year.I cannot take alprazolam due to my health condition.I am 12 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Staccato alprazolam
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Staccato alprazolam for use?
"There is robust clinical data attesting to the safety of Staccato alprazolam, as this medication has completed Phase 3 trials."
Answered by AI
Do different hospitals offer this research opportunity to patients?
"30 different sites are currently running this trial, these include Ep0165 50364 in Philadelphia, Ep0165 50299 in New Brunswick, and Ep0165 50298 in New Orleans."
Answered by AI
To the best of your knowledge, has there been a similar study like this one before?
"3 ongoing trials for Staccato alprazolam are taking place in 28 cities and 10 countries. The first one started in 2021 and completed Phase 3 in that same year. The sponsor of the trial, UCB Biopharma SRL, recruited 250 patients total. Since then, 57 more studies have been completed."
Answered by AI
What are the projected benefits of this research?
"The purpose of this study, which will occur over the course of 48 months, is to observe the frequency of serious adverse events. Additionally, the study hopes to see treatment success rates after IMP administration for seizures occurring in the first 6 months and for seizures during the first 12 months with no recurrence after 2 hours. Finally, the study will also take note of the frequency of respiratory adverse events."
Answered by AI
What other research has explored the effects of Staccato alprazolam?
"Currently, there are 3 ongoing studies involving Staccato alprazolam with 2 being in Phase 3. Although a large portion of the research is based in Lublin, New jersey, there are a total of 153 locations running trials."
Answered by AI
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