Study on the Safety of Alprazolam for Treating Long Seizures in Patients Aged 12 and Older

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What is this study about?

This clinical trial is focused on studying the safety of a treatment for people aged 12 and older who experience stereotypical prolonged seizures. These are types of seizures that last longer than usual and can occur in individuals with conditions like epilepsy. The treatment being tested is called Staccato® alprazolam, which is a medication delivered through a special inhalation device. This device allows the medication to be inhaled directly into the lungs, providing a quick way to administer the drug during a seizure episode.

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato® alprazolam. Participants in the study will use the inhalation device to take the medication when they experience a seizure. The study will monitor how well participants tolerate the medication over time and will track any side effects that may occur. Some participants will receive a placebo, which looks like the medication but does not contain the active substance.

Throughout the study, researchers will collect information on the frequency of any side effects and how often these side effects lead to participants stopping the study. The study will also look at how successful the treatment is in managing seizures within the first year and whether there are any breathing-related side effects. This information will help determine if Staccato® alprazolam is a safe and effective treatment option for managing prolonged seizures in both children and adults.

1 joining the study

Upon joining the study, the participant must be at least 12 years old and have a caregiver who is at least 18 years old. The caregiver should be able to recognize and observe the participant’s condition.

The participant should have a diagnosis of epilepsy with a history of prolonged seizures. This includes specific types of seizures such as generalized seizures starting with absence or myoclonic seizures lasting at least 5 minutes, or focal seizures lasting at least 3 minutes.

2 medication administration

The participant will receive Staccato alprazolam, which is an inhalation powder pre-dispensed for use. This medication is designed to treat prolonged seizures.

The dosage and frequency of administration will be determined by the study protocol and the participant’s specific needs.

3 monitoring and evaluation

Throughout the study, the participant will be monitored for any treatment-emergent adverse events (TEAEs). This includes any new or worsening symptoms that occur after starting the medication.

The study will also evaluate the frequency of serious TEAEs and any events that lead to withdrawal from the study.

4 treatment success assessment

The study will assess the success of the treatment after the administration of the investigational medicinal product (IMP) for seizures occurring within the first 12 months.

Success is defined as no recurrence of seizures within 2 hours after administration.

5 completion of the study

The study is expected to continue until May 22, 2026. Participants will be involved in the study until this date or until they choose to withdraw.

The primary goal is to evaluate the long-term safety and tolerability of Staccato alprazolam in treating prolonged seizures.

Who Can Join the Study?

The participant must be at least 12 years old at the time of signing the informed consent or giving assent if required.
The participant must have a study caregiver who is at least 18 years old at the time of signing the informed consent. The caregiver must be able to recognize and observe the participant.
The participant must have a confirmed diagnosis of epilepsy, which is a condition that affects the brain and causes seizures. This can be either focal epilepsy, generalized epilepsy, or a combination of both.
The participant must have a documented history of specific types of seizures, which include at least one of the following:
- Generalized seizure episodes that start with a series of absence seizures (brief lapses in awareness) or myoclonic seizures (sudden, brief muscle jerks) lasting at least 5 minutes in total.
- Episodes of a focal seizure lasting at least 3 minutes. A focal seizure affects only one part of the brain.
- Episodes of a focal seizure or a series of myoclonic seizures lasting at least 90 seconds, followed by a generalized or bilateral tonic-clonic seizure (a seizure that affects both sides of the brain and involves muscle stiffness and jerking) lasting at least 3 minutes in total.
Before the screening visit, the participant must have completed a study using Staccato alprazolam, which is a medication being tested in the study.
For certain treatment groups, before the screening visit, the participant must have completed a specific Phase 3 study with Staccato alprazolam at a clinical site in the EU, UK, or UA, and must have experienced a seizure treated with the investigational medication during the outpatient treatment period.

Who Cannot Join the Study?

Patients who have a history of allergic reactions to the study medication or similar medications.
Patients with severe liver or kidney problems, as these organs help process medications in the body.
Patients who are pregnant or breastfeeding, to avoid any potential risks to the baby.
Patients with a history of substance abuse, which means having problems with drugs or alcohol.
Patients who are currently participating in another clinical trial, to ensure accurate results.
Patients with certain mental health conditions that might interfere with the study.
Patients who have had a major surgery recently, as recovery might affect the study.
Patients with uncontrolled high blood pressure, which means blood pressure that is not well-managed.
Patients with certain heart conditions that could be affected by the study medication.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet	Budapest	Hungary
Hospital Universitario De Navarra	Pamplona	Spain
NZOZ IGNIS dr med. Alicja Łobinska	Swidnik	Poland
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Specjalistyczne Gabinety Lekarskie Landa	Cracow	Poland

Other Sites

Site Name	City	Country
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Hospital Ruber Internacional	Madrid	Spain
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Gesellschaft Fuer Epilepsieforschung	Bielefeld	Germany
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Cerebrovaskularni poradna s.r.o.	Moravska Ostrava A Privoz	Czechia
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet	Balassagyarmat	Hungary
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD	Blagoevgrad	Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Debrecen	Debrecen	Hungary
Semmelweis University	Budapest	Hungary
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Fakultni Thomayerova nemocnice	Prague	Czechia
Forbeli s.r.o.	Prague	Czechia
Drwbentq Kefp	Kehl	Germany
Meicheazyobwl Bmkqnfmn Zh Apecuhl Lkmrcqby Hjzhrb Ae	Pazardzhik	Bulgaria
Gwmxep Uuuasbnzzr Fhrkyzdsi	Frankfurt	Germany
Migcxejr Mulciuh Adwuhtq	Pleven	Bulgaria
Fhfgrtef nqmycmlor Minnf a Hscqldf	Prague	Czechia
Ulxasetjso Dtiql Stdse Db Riiw Ld Sgfwvstq	Rome	Italy
Hcgiyggn Vpux dgboxtup	Barcelona	Spain
Cuevzr db Nedfweuqbk Aovurvgh	Sevilla	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	26.09.2022
Czechia	Recruiting	26.09.2022
Germany	Recruiting	26.09.2022
Hungary	Recruiting	26.09.2022
Italy	Recruiting	26.09.2022
Poland	Recruiting	26.09.2022
Spain	Recruiting	26.09.2022

Trial locations

Investigated drugs:

Alprazolam

Staccato Alprazolam is a medication being studied for its safety and tolerability in people aged 12 and older who experience prolonged seizures. It is designed to be fast-acting, helping to quickly manage seizure episodes. The study aims to understand how well patients tolerate this medication over a longer period.

Prolonged Seizure – A prolonged seizure is a type of seizure that lasts longer than the typical duration, often exceeding five minutes. It can occur as part of various seizure disorders and may involve convulsions, loss of consciousness, or other neurological symptoms. During a prolonged seizure, the brain’s electrical activity becomes abnormal, leading to intense and sustained physical reactions. These seizures can be triggered by various factors, including stress, lack of sleep, or missed medication. The progression of a prolonged seizure can vary, with some individuals experiencing a single episode while others may have recurrent events. Managing the duration and frequency of these seizures is crucial to prevent potential complications.

Trial ID:

2023-508868-30-00

Protocol code:

EP0165

NCT ID:

NCT05076617

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety of Alprazolam for Treating Long Seizures in Patients Aged 12 and Older

What is this study about?

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