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Benzodiazepine

Staccato Alprazolam for Epilepsy

Phase 3
Recruiting
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is receiving a regimen of antiseizure medications (ASMs) that has been stable for 30 days prior to the Screening Visit
Participant must be ≥12 years of age at the Baseline/Randomization Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of imp treatment up to the safety follow-up visit (week 19)
Awards & highlights
Pivotal Trial

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.

Who is the study for?
This trial is for people aged 12 and older with focal or generalized epilepsy who have had at least four prolonged seizures in the past six months. They must be on a stable medication regimen, not pregnant or breastfeeding, and agree to use contraception. Exclusions include drug abuse within the last year, sensitivity to alprazolam or similar drugs, certain respiratory issues, glaucoma, long QT syndrome, unstable psychiatric disorders, recent changes in VNS therapy settings.Check my eligibility
What is being tested?
The study tests Staccato alprazolam's ability to quickly stop a seizure within 90 seconds without recurrence for up to two hours compared to a placebo. Participants will receive one dose of either the actual drug or placebo during an episode.See study design
What are the potential side effects?
Staccato alprazolam may cause drowsiness, dizziness, headache, blurred vision and can affect coordination. It might also lead to dependency if used regularly over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My seizure medication dose has been the same for the last 30 days.
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I am 12 years old or older.
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I have a caregiver over 18 who can observe and recognize my seizures.
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I have been diagnosed with epilepsy and have a history of long-lasting seizures.
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I've had 4 or more long seizures in the last 6 months, with 2 happening in the last 3 months.
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My recent brain scans show no progressive neurological disorder.
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I am not pregnant, not breastfeeding, and follow specific birth control measures.
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I can sign the consent form and follow the study's rules.
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I agree to use birth control and not donate sperm for 7 days after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of imp treatment up to the safety follow-up visit (week 19)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of imp treatment up to the safety follow-up visit (week 19) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment success for the treated seizure with no recurrence up to 2 hours
Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration
Secondary outcome measures
Frequency of respiratory treatment emergent adverse events (TEAEs)
Number of subsequent seizure(s) up to 2 hours after IMP administration
Time from IMP administration to cessation of the treated seizure
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Staccato alprazolam ArmExperimental Treatment1 Intervention
Participants randomized to this arm will receive a single dose of Staccato alprazolam by inhalation.
Group II: Placebo ArmPlacebo Group1 Intervention
Participants randomized to this arm will receive a single dose of placebo 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
98 Previous Clinical Trials
20,901 Total Patients Enrolled
14 Trials studying Epilepsy
2,350 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
202 Previous Clinical Trials
44,016 Total Patients Enrolled
49 Trials studying Epilepsy
11,823 Patients Enrolled for Epilepsy

Media Library

Staccato alprazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05077904 — Phase 3
Epilepsy Research Study Groups: Staccato alprazolam Arm, Placebo Arm
Epilepsy Clinical Trial 2023: Staccato alprazolam Highlights & Side Effects. Trial Name: NCT05077904 — Phase 3
Staccato alprazolam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077904 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Who else is applying?

What site did they apply to?
Ep0162 50517
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~9 spots leftby Apr 2024