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

3 1

What is this study about?

This clinical trial is focused on studying the effectiveness and 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 be part of conditions like epilepsy. The treatment being tested is called Staccato Alprazolam, which is a special form of the medication alprazolam. It is delivered through a handheld device that allows the medicine to be inhaled as a powder. This study will compare the effects of Staccato Alprazolam with a placebo to see how well it can stop a seizure quickly and prevent another one from happening soon after.

The main goal of the study is to determine if a single dose of Staccato Alprazolam can stop a seizure within 90 seconds and prevent any more seizures for up to two hours. Participants will be randomly assigned to receive either the Staccato Alprazolam or a placebo. The study will take place over a period of time, during which participants will be monitored to see how they respond to the treatment. The study will also look at how long it takes for the seizure to stop after taking the medication and whether there are any side effects related to breathing.

Participants will be involved in the study as outpatients, meaning they will not need to stay in a hospital. The study aims to provide valuable information on whether Staccato Alprazolam is a safe and effective option for treating long seizures in both children and adults. The results could help improve treatment options for those who experience these types of seizures.

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 seizures.

The participant should have a history of prolonged seizures and must have experienced at least four episodes in the past six months, with the last two episodes occurring within three months before joining the study.

2 treatment administration

The participant will receive a single administration of Staccato alprazolam or a placebo. The medication is in the form of an inhalation powder, pre-dispensed for use.

The objective is to rapidly stop a seizure episode within 90 seconds and prevent any recurrence for up to two hours after administration.

3 monitoring period

The participant will be monitored for treatment success, defined as no recurrence of the treated seizure after two hours.

Secondary outcomes include no recurrence after four and six hours, the time taken for the seizure to stop after administration, and the frequency of any respiratory side effects.

4 follow-up

The participant will be observed for any subsequent seizures up to two hours after the medication is given.

The time to the first subsequent seizure, if any, will also be recorded.

Who Can Join the Study?

The participant must be at least 12 years old at the start of the study.
The participant must have a caregiver who is at least 18 years old. This caregiver can be a family member, friend, or someone who takes care of the participant daily and knows how to recognize and observe the participant’s seizures.
The participant must have a confirmed diagnosis of epilepsy, which is a condition that causes seizures. The participant should have a history of specific types of prolonged seizures, such as:
- Generalized seizures that start with a series of absence or myoclonic seizures lasting at least 5 minutes.
- Focal seizures lasting at least 3 minutes.
- Focal seizures or a series of myoclonic seizures lasting at least 90 seconds, followed by a generalized seizure lasting at least 3 minutes.
Before joining the study, the participant must have had at least 4 episodes of prolonged seizures in the past 6 months, with the last 2 episodes occurring within 3 months before the study starts.
The participant must have had a brain scan, such as a CT or MRI, within the last 5 years that shows no progressive brain disorder.
The participant must be on a stable treatment plan with anti-seizure medications for at least 30 days before the study starts. This means no new medications have been added or removed, although dose adjustments are allowed, except for certain medications called benzodiazepines.
Both male and female participants must agree to use birth control during the study and for a short period after receiving the study medication. Male participants must also agree not to donate sperm during this time.
Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for 30 days after receiving the study medication.
The participant must be able to understand and sign a consent form, agreeing to follow the study’s rules and requirements. If the participant is a minor, they must provide assent, which is a form of agreement suitable for their age.
The participant’s caregiver must also be able to understand and sign a consent form, agreeing to follow the study’s rules and requirements.

Who Cannot Join the Study?

Patients who have a medical condition other than a stereotypical prolonged seizure may not be eligible. A stereotypical prolonged seizure is a type of seizure that lasts longer than usual and follows a predictable pattern.
Patients who are not within the specified age range for the study may be excluded. The age range includes children, adolescents, and adults.
Both male and female patients are considered for the study, but certain conditions specific to gender may lead to exclusion.
Patients who are part of a vulnerable population, which means they may have additional health or social challenges, might not be eligible.

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
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
University Of Debrecen	Debrecen	Hungary
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Semmelweis University	Budapest	Hungary
Robert Debre University Hospital	Paris	France
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Fakultni Thomayerova nemocnice	Prague	Czechia
Forbeli s.r.o.	Prague	Czechia
NZOZ IGNIS dr med. Alicja Lobinska	Swidnik	Poland
Djquntce Kabk	Kehl	Germany
Urmyomoyaa Hhcnexkxo Pnojc Smgffrbduqz Crzxlva Ffdk	Paris	France
Mojgbivacgcrt Bgjcmpyd Zi Amdsbdh Lkohknkp Hmeqct Az	Pazardzhik	Bulgaria
Fxyuvjia ncyeqmtmk Mvrpc a Hgvzjnu	Prague	Czechia
Ghafog Uejldibwch Fzcwvltcv	Frankfurt	Germany
Mxhqdgaw Mknmxri Awyzuvc	Pleven	Bulgaria
Ufzvgbygnz Dtlpm Ssouv Do Rjki Lv Skvubkik	Rome	Italy
Hjrhccqz Vsfi dbvsxcpn	Barcelona	Spain
Cmqgni df Nuprfnidme Alvfqppb	Sevilla	Spain
Hulntgiw Uiecjwxufypaxr Sujpxlynuw &nptayz Hngenmh dn Hgyoktbtrly	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	01.09.2022
Czechia	Recruiting	01.09.2022
France	Recruiting	01.09.2022
Germany	Recruiting	01.09.2022
Hungary	Recruiting	01.09.2022
Italy	Recruiting	01.09.2022
Poland	Recruiting	01.09.2022
Spain	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Alprazolam

Staccato Alprazolam is a medication being studied for its ability to quickly stop prolonged seizures in individuals aged 12 and older. It is designed to be administered in a way that allows it to act rapidly, with the goal of ending a seizure episode within 90 seconds and preventing any further seizures for up to 2 hours after taking the medication.

Stereotypical Prolonged Seizure – This condition involves seizures that last longer than usual, often exceeding five minutes, and can be difficult to stop without medical intervention. These seizures are characterized by repetitive, stereotyped movements or behaviors that are consistent with previous episodes experienced by the individual. During a prolonged seizure, the person may lose consciousness, experience muscle stiffness, or have jerking movements. The condition can occur in individuals with epilepsy or other neurological disorders. It is important to monitor the duration and frequency of these seizures, as they can lead to further complications if not managed properly.

Trial ID:

2024-510950-29-00

Protocol code:

EP0162

NCT ID:

NCT05077904

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?