What side effects are associated with this type of intervention?

Common treatments for epilepsy that enhance GABAergic activity via the GABA-A receptor, such as benzodiazepines (e.g., alprazolam), often have side effects including drowsiness, dizziness, fatigue, and impaired coordination. Long-term use can lead to tolerance, dependence, and withdrawal symptoms. Other potential side effects include cognitive impairment, anterograde amnesia, and, in some cases, paradoxical reactions like increased anxiety or agitation.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of epilepsy enhance GABAergic activity via the GABA-A receptor. Benzodiazepines such as diazepam, lorazepam, and clonazepam are commonly used for their anticonvulsant properties, working by enhancing the inhibitory effects of GABA at the GABA-A receptor. These medications are typically administered orally or intravenously. Another notable drug is midazolam, which can be administered intranasally for rapid effect in acute seizure management. While these treatments share a similar mechanism of action with Staccato alprazolam, the latter's unique delivery through a rapid inhalation system represents an innovative approach in epilepsy management.

What other types of research exist?

Promising novel alternatives to Staccato alprazolam for epilepsy patients include: 1) Cannabidiol (CBD) - shown to reduce seizure frequency in conditions like Lennox-Gastaut and Dravet syndromes. 2) Ganaxolone - a synthetic neuroactive steroid approved for CDKL5 deficiency disorder-related seizures. 3) Antisense oligonucleotide therapies - targeting specific genetic mutations in epilepsy. 4) Gene therapy using viral vectors - aiming to correct underlying genetic causes of epilepsy.

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying the long-term safety and tolerability of Staccato alprazolam, a fast-acting inhaled medication for anxiety and panic disorders. Staccato alprazolam is a fast-acting inhaled formulation of alprazolam, which has been widely used and studied for its efficacy in treating anxiety and panic disorders.

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.

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.

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 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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of TEAEs leading to withdrawal from study

Frequency of serious TEAEs

Frequency of treatment-emergent adverse events (TEAEs)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

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

0 / 11Eligibility criteria met

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.