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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))
Must not have
Participant has a history or presence of acute narrow-angle glaucoma
Participant is taking nonselective beta blockers on a chronic basis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to the end of study visit (up to 48 months)
Awards & highlights

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 below
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I have been diagnosed with epilepsy and have a history of long-lasting seizures.
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I have completed a study with Staccato alprazolam.
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I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had acute narrow-angle glaucoma.
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I am regularly taking medication that affects my heart and blood pressure.
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I regularly take opioids or sedatives.
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I am not allergic to the trial medication or similar drugs, including albuterol.
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I have a serious lung condition other than mild asthma, or I've recently coughed up blood or had a collapsed lung.
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I am currently taking medication that strongly affects liver enzyme activity.
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I have seizures that might not be due to epilepsy.
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I cannot take alprazolam due to my health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to the end of study visit (up to 48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to the end of study visit (up to 48 months) for reporting.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for epilepsy often work by enhancing GABAergic activity, blocking sodium channels, or modulating neurotransmitter release. Staccato alprazolam, for example, enhances GABAergic activity via the GABA-A receptor, which increases inhibitory neurotransmission and helps prevent seizures. Sodium channel blockers, like carbamazepine, stabilize neuronal membranes and reduce excitability. These mechanisms are crucial for epilepsy patients as they help control seizures, improve quality of life, and reduce the risk of seizure-related injuries.

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Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
105 Previous Clinical Trials
21,539 Total Patients Enrolled
15 Trials studying Epilepsy
2,470 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
208 Previous Clinical Trials
44,899 Total Patients Enrolled
50 Trials studying Epilepsy
11,854 Patients Enrolled for Epilepsy

Media Library

Staccato alprazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05076617 — Phase 3
Epilepsy Research Study Groups: Staccato alprazolam
Epilepsy Clinical Trial 2023: Staccato alprazolam Highlights & Side Effects. Trial Name: NCT05076617 — Phase 3
Staccato alprazolam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076617 — Phase 3
~124 spots leftby May 2026
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