Clinical trial • Phase IV • Neurology

ALPRAZOLAM for Prolonged seizure|Stereotypical prolonged seizure

Phase IV trial of ALPRAZOLAM for Prolonged seizure|Stereotypical prolonged seizure.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Prolonged seizure|Stereotypical prolonged seizure
Trial Stage
Phase IV
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
30-04-2024
First CTIS Authorization Date
07-06-2024

Trial design

open-label, placebo matching staccato® alprazolam and without active substance is listed as a product; no dose or schedule specified in the source-controlled Phase IV trial in Poland, Spain, Germany and others.

Open Label
Yes
Comparator
Placebo matching Staccato® alprazolam and without active substance is listed as a product; no dose or schedule specified in the source
Target Sample Size
181

Eligibility

Recruits 181 paediatric patients.

Vulnerable Population
Includes minors: participants aged ≥12 years (adolescents). Consent/assent handling: "Participant must be ≥12 years of age at the time of signing informed consent (or giving assent, where required)" and a study caregiver ≥18 years of age must be present at time of signing informed consent (caregiver must be able to recognize and observe the participant). Age-specific informed consent and assent documents are provided (documents for ages 12-17, parental/guardian and caregiver forms are listed in the public documents).

Inclusion criteria

  • {"criterion_text":"- Participant must be ≥12 years of age at the time of signing informed consent (or giving assent, where required) - Participant must have a study caregiver ≥18 years of age at the time of signing the informed consent; the study caregiver(s) must be able to recognize and observe the participant - 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 that includes at least 1 of the following: a) Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes b) Episodes of a focal seizure with a minimum duration of 3 minutes c) Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes - Prior to the Screening Visit, participant completed a study using Staccato alprazolam Additional inclusion criteria for treatment arms 2 to 5: Prior to the Screening Visit, the participant completed the Phase 3 efficacy study with Staccato alprazolam (EP0162) at a clinical site located in the EU, UK, and UA, and experienced an IMP-treated seizure during the Outpatient Treatment Period."}

Exclusion criteria

  • {"criterion_text":"- Participant has a current history of alcohol or drug use disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year - Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparable drugs (and/or an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country- specific requirements) - Participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8-weeks prior to the Screening Visit - Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures - Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation) - Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence of hemoptysis or pneumothorax - Participant has had a positive antigen test for SARS-CoV-2 and experienced moderate to severe signs/symptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and/or oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to Screening - Participant has experienced a severe upper respiratory tract infection within 4 weeks or severe bronchitis/pneumonia within 3 months before the Screening Visit - Participant has a history or presence of acute narrow-angle glaucoma - Participant has a condition for which oral alprazolam is contraindicated as per the regional labeling (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome) - Participant has a history or presence of long QT syndrome, a family history of sudden death due to long QT syndrome, or unexplained syncope - Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone - Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis - Participant is taking nonselective beta blockers on a chronic basis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Frequency of treatment-emergent adverse events (TEAEs)\n- 2. Frequency of TEAEs leading to withdrawal from study\n- 3. Frequency of serious TEAEs","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months\n- 2. Treatment success after IMP administration with no recurrence after 2 hours for seizures occurring within first 12 months\n- 3. Frequency of respiratory TEAEs","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
True; Center For Information And Study On Clinical Research Participation Inc.|Epilepsy Study Consortium Inc.
Planned Sample Size
181
Recruitment Window Months
84
Consent Approach
Participants ≥12 years provide informed consent or give assent where required; a study caregiver ≥18 years of age must sign the informed consent and be able to observe the participant. Age-specific information and consent forms are provided (documents for adolescents 12-17, caregiver forms, parent/guardian forms) and are available in country-specific languages as evidenced by multiple country ICF documents in the public dossier.

Methods

  • Patient recruitment contracted to Longboat Clinical Limited (role: Patient Recruitment; contact patrick.barrett@advarra.com)
  • Engagement with patient organisation/advocacy groups (e.g., Center For Information And Study On Clinical Research Participation Inc.; contact mscanlon@ciscrp.org) to support recruitment/awareness
  • Country-specific recruitment arrangements submitted (recruitment documents present per MS such as ep0165-pl-rec-proc-en-public and ESP Recruitment Other English EP0165)

Geography

Total Number Of Sites
40
Total Number Of Participants
111

Poland

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
18
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
#40091; Neurology
Principal Investigator Name
Agata Klosek
Principal Investigator Email
klosek@twojaprzychodnia.com
Contact Person Name
Agata Klosek
Contact Person Email
klosek@twojaprzychodnia.com
Site Name
Specjalistyczne Gabinety Lekarskie Landa
Department Name
#40842; Neurology
Principal Investigator Name
Magdalena Bosak
Principal Investigator Email
magdalenabosak@wp.pl
Contact Person Name
Magdalena Bosak
Contact Person Email
magdalenabosak@wp.pl
Site Name
NZOZ IGNIS dr med. Alicja Lobinska
Department Name
#40678; Neurology
Principal Investigator Name
Alicja Lobinska
Principal Investigator Email
alalob@tlen.pl
Contact Person Name
Alicja Lobinska
Contact Person Email
alalob@tlen.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
#40677; Oddzial Neurologiczny
Principal Investigator Name
Waldemar Fryze
Principal Investigator Email
w.fryze@wp.pl
Contact Person Name
Waldemar Fryze
Contact Person Email
w.fryze@wp.pl
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Department Name
#40676; Neurology
Principal Investigator Name
Jacek Gawlowicz
Principal Investigator Email
gawlowiczj@wp.pl
Contact Person Name
Jacek Gawlowicz
Contact Person Email
gawlowiczj@wp.pl
Site Name
Centrum Medyczne Neuromed Sp. z o.o.
Department Name
#40707; Neurology
Principal Investigator Name
Pawel Lisewski
Principal Investigator Email
lisewski.p@gmail.com
Contact Person Name
Pawel Lisewski
Contact Person Email
lisewski.p@gmail.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
#40502; Neurology
Principal Investigator Name
Marta Zolnowska
Principal Investigator Email
marta.zolnowska@gmail.com
Contact Person Name
Marta Zolnowska
Contact Person Email
marta.zolnowska@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
15
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
#40453; Unitat de Recerca de Neurologia
Principal Investigator Name
Belen Diaz Fernandez
Principal Investigator Email
Bdiaz@mutuaterrassa.cat
Contact Person Name
Belen Diaz Fernandez
Contact Person Email
Bdiaz@mutuaterrassa.cat
Site Name
Hospital Ruber Internacional
Department Name
#40540; Neurology
Principal Investigator Name
Antonio Gil-Nagel
Principal Investigator Email
agnagel@neurologiaclinica.es
Contact Person Name
Antonio Gil-Nagel
Contact Person Email
agnagel@neurologiaclinica.es
Site Name
Centro De Neurologia Avanzada S.L.P.
Department Name
#40668; Neurología
Principal Investigator Name
Juan Rodriguez Uranga
Principal Investigator Email
uranganeuro@gmail.com
Contact Person Name
Juan Rodriguez Uranga
Contact Person Email
uranganeuro@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
#40160; Neurología
Principal Investigator Name
Manuel Toledo Argany
Principal Investigator Email
manuel.toledo@vallhebron.cat
Contact Person Name
Manuel Toledo Argany
Contact Person Email
manuel.toledo@vallhebron.cat
Site Name
Clinica Universidad De Navarra
Department Name
#40352; Neurología
Principal Investigator Name
Rocío Sánchez Carpintero Abad
Principal Investigator Email
rsanchezc@unav.es
Contact Person Name
Rocío Sánchez Carpintero Abad
Contact Person Email
rsanchezc@unav.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
#40230; Neurología Pediátrica
Principal Investigator Name
Vicente Villanueva Haba
Principal Investigator Email
vevillanuevah@yahoo.es
Contact Person Name
Vicente Villanueva Haba
Contact Person Email
vevillanuevah@yahoo.es
Site Name
Bellvitge University Hospital
Department Name
#40157; Neurologia
Principal Investigator Name
Merce Falip Centellas
Principal Investigator Email
mfalip@bellvitgehospital.cat
Contact Person Name
Merce Falip Centellas
Contact Person Email
mfalip@bellvitgehospital.cat
Site Name
Hospital Universitario Y Politecnico La Fe (duplicate entry for Valencia site listed)
Department Name
#40230; Neurología Pediátrica
Principal Investigator Name
Vicente Villanueva Haba
Principal Investigator Email
vevillanuevah@yahoo.es
Contact Person Name
Vicente Villanueva Haba
Contact Person Email
vevillanuevah@yahoo.es

Germany

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
15
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
#40023; Klinik für molekulare Neurologie
Principal Investigator Name
Hajo Hamer
Principal Investigator Email
hajo.hamer@uk-erlangen.de
Contact Person Name
Hajo Hamer
Contact Person Email
hajo.hamer@uk-erlangen.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
#40529; Klinik und Poliklinik für Neurologie
Principal Investigator Name
Susanne Knake
Principal Investigator Email
knake@med.uni-marburg.de
Contact Person Name
Susanne Knake
Contact Person Email
knake@med.uni-marburg.de
Site Name
Diakonie Kork
Department Name
#40689
Principal Investigator Name
Bernhard Steinhoff
Principal Investigator Email
bsteinhoff@epilepsiezentrum.de
Contact Person Name
Bernhard Steinhoff
Contact Person Email
bsteinhoff@epilepsiezentrum.de
Site Name
Gesellschaft Fuer Epilepsieforschung
Department Name
#40685; Epilepsiezentrum Bethel
Principal Investigator Name
Christian Brandt
Principal Investigator Email
christian.brandt@mara.de
Contact Person Name
Christian Brandt
Contact Person Email
christian.brandt@mara.de
Site Name
Goethe University Frankfurt
Department Name
#40645; Zentrum für Neurologie und Neurochirurgie
Principal Investigator Name
Felix Rosenow
Principal Investigator Email
rosenow@med.uni-frankfurt.de
Contact Person Name
Felix Rosenow
Contact Person Email
rosenow@med.uni-frankfurt.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
#40683; Klinik für Neurologie
Principal Investigator Name
Bettina Schmitz
Principal Investigator Email
bettina.schmitz@vivantes.de
Contact Person Name
Bettina Schmitz
Contact Person Email
bettina.schmitz@vivantes.de
Site Name
Gesellschaft Fuer Epilepsieforschung (additional site entry)
Department Name
#40685; Epilepsiezentrum Bethel
Principal Investigator Name
Christian Brandt
Principal Investigator Email
christian.brandt@mara.de
Contact Person Name
Christian Brandt
Contact Person Email
christian.brandt@mara.de

Hungary

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
15
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Orszagos Mentalis Ideggyogyaszati Es Idegsebeszeti Intezet
Department Name
#40673; Juhász Pál Epilepszia Központ
Principal Investigator Name
Anna Kelemen
Principal Investigator Email
kelemenanna@hotmail.com
Contact Person Name
Anna Kelemen
Contact Person Email
kelemenanna@hotmail.com
Site Name
Dr. Kenessey Albert Korhaz Rendelointezet
Department Name
#40666; Pulmonology
Principal Investigator Name
Viktor Bauer
Principal Investigator Email
dr.bauer.viktor@gmail.com
Contact Person Name
Viktor Bauer
Contact Person Email
dr.bauer.viktor@gmail.com
Site Name
University Of Debrecen
Department Name
#40653; Altalanos Gyermekgyogyaszat
Principal Investigator Name
Monika Bessenyei
Principal Investigator Email
besmoni@gmail.com
Contact Person Name
Monika Bessenyei
Contact Person Email
besmoni@gmail.com
Site Name
Semmelweis University
Department Name
#40704; Tűzoltó utcai részleg
Principal Investigator Name
Kristóf Márk Farkas
Principal Investigator Email
kristofm.farkas@gmail.com
Contact Person Name
Kristóf Márk Farkas
Contact Person Email
kristofm.farkas@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
01-07-2024
Processing Time Days
39
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
#40651; Clinic of Nerve Disorders for Paroxysmal states, Second Department of Epilepsy
Principal Investigator Name
Ivan Milanov
Principal Investigator Email
ubalnp@yahoo.com
Contact Person Name
Ivan Milanov
Contact Person Email
ubalnp@yahoo.com
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Higiya AD
Department Name
#40708; Neurology Department
Principal Investigator Name
Hristina Chilingirova-Ignatieva
Principal Investigator Email
chilingirova.hristina@abv.bg
Contact Person Name
Hristina Chilingirova-Ignatieva
Contact Person Email
chilingirova.hristina@abv.bg
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
#40650; Department of Neurology
Principal Investigator Name
Sasho Kastrev
Principal Investigator Email
kastrev@hotmail.com
Contact Person Name
Sasho Kastrev
Contact Person Email
kastrev@hotmail.com
Site Name
Military Medical Academy
Department Name
#40709; Neurology department
Principal Investigator Name
Plamen Georgiev
Principal Investigator Email
tzvetanovplamen@hotmail.com
Contact Person Name
Plamen Georgiev
Contact Person Email
tzvetanovplamen@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
19
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
#40063; Neurologicka klinika
Principal Investigator Name
Jana Zarubova
Principal Investigator Email
jana.zarubova@epileptolog.eu
Contact Person Name
Jana Zarubova
Contact Person Email
jana.zarubova@epileptolog.eu
Site Name
Fakultni Thomayerova nemocnice
Department Name
#40714; Neurologicka klinika
Principal Investigator Name
Dana Vyskocilova
Principal Investigator Email
dana.vyskocilova@ftn.cz
Contact Person Name
Dana Vyskocilova
Contact Person Email
dana.vyskocilova@ftn.cz
Site Name
Cerebrovaskularni poradna s.r.o.
Department Name
#40672
Principal Investigator Name
Michal Bar
Principal Investigator Email
michal.bar@fno.cz
Contact Person Name
Michal Bar
Contact Person Email
michal.bar@fno.cz
Site Name
Forbeli s.r.o.
Department Name
#40671
Principal Investigator Name
Michal Bajacek
Principal Investigator Email
mbajacek@yahoo.co.uk
Contact Person Name
Michal Bajacek
Contact Person Email
mbajacek@yahoo.co.uk
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
#40670; I. Neurologicka klinika
Principal Investigator Name
Jitka Kocvarova
Principal Investigator Email
jitka.krizova@fnusa.cz
Contact Person Name
Jitka Kocvarova
Contact Person Email
jitka.krizova@fnusa.cz

Italy

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
34
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Neurological Institute Foundation Casimiro Mondino
Department Name
#40477; Regional Site for Epilepsy
Principal Investigator Name
Carlo Andrea Galimberti
Principal Investigator Email
carloandrea.galimberti@mondino.it
Contact Person Name
Carlo Andrea Galimberti
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
#40257; Dermatologia
Principal Investigator Name
Francesca Izzi
Principal Investigator Email
fraizzi@tin.it
Contact Person Name
Francesca Izzi
Contact Person Email
fraizzi@tin.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
#40674; cardiologia
Principal Investigator Name
Flavio Villani
Principal Investigator Email
flavio.villani@hsanmartino.it
Contact Person Name
Flavio Villani
Contact Person Email
flavio.villani@hsanmartino.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
#40675; Neurologia
Principal Investigator Name
Carlo Di Bonaventura
Principal Investigator Email
c.dibonaventura@policlinicoumberto1.it
Contact Person Name
Carlo Di Bonaventura
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
#40144; U.O.C. Neurologia 7 Struttura Semplice Diagnostica Epilettologica Integrata
Principal Investigator Name
Laura Canafoglia
Principal Investigator Email
Laura.Canafoglia@istituto-besta.it
Contact Person Name
Laura Canafoglia

Sponsor

Primary sponsor

Full Name
UCB Biopharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Longboat Clinical Limited
Responsibilities
Patient Recruitment
Name
Ppd Inc.
Responsibilities
PK analysis for overdose and liver events only
Name
Iqvia Laboratories Limited
Responsibilities
Central laboratory
Name
Eresearchtechnology Inc.
Responsibilities
Central ECG reading

Third parties

  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"code 11 (role listed in sponsor third parties)","organisation_type":"Patient organisation/association"}
  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG reading","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 6 (listed duty)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"PK analysis for overdose and liver events only","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code 7 (listed duty)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Epilepsy Study Consortium Inc.","duties_or_roles":"code 13 (listed duty)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Formedix Limited","duties_or_roles":"code 6 (listed duty)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"Central laboratory","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code 3 (listed duty)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"code 10 (listed duty)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
alprazolam
Active Substance
ALPRAZOLAM
Modality
Small molecule
Routes Of Administration
INHALATION USE
Route
INHALATION USE
Maximum Dose
2 mg (maxDailyDoseAmount: 2 mg)
Investigational Product Name
Placebo matching Staccato® alprazolam and without active substance
Modality
Other
Combination Treatment
Yes

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