Clinical trial • Not applicable • Neurology

BRIVARACETAM for Childhood absence epilepsy | Juvenile absence epilepsy

Not applicable trial of BRIVARACETAM for Childhood absence epilepsy | Juvenile absence epilepsy. open-label, none/not specified-controlled.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Childhood absence epilepsy | Juvenile absence epilepsy
Trial Stage
Not applicable
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
02-04-2024
First CTIS Authorization Date
19-07-2024

Trial design

open-label, none/not specified-controlled Not applicable trial across 16 sites in Italy, Romania, Spain and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
39
Trial Duration For Participant
1080

Eligibility

Recruits 39 paediatric patients.

Pregnancy Exclusion
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.
Vulnerable Population
Vulnerable population selected. Minors (pediatric participants) are included; participants must be capable of and provide informed consent/assent, and the participant’s parent/legal representative/caregiver must provide signed informed consent for minor participants. Multiple country-specific informed consent/assent documents are provided (local-language ICFs and assent forms).

Inclusion criteria

  • {"criterion_text":"- Participants who previously participated in EP0132 and/or N01269 and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) - Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator - Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP. - Capable of and provides informed consent/assent, and the participant’s parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol"}

Exclusion criteria

  • {"criterion_text":"- Participant has a history or presence of paroxysmal nonepileptic seizures - Participant has severe medical, neurological, or psychiatric disorders or laboratory values which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation - Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator’s assessment - Participant has active suicidal ideation prior to study entry as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (for participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately to a Mental Healthcare Professional - Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant’s ability to participate in this study - Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure - Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin - Participant is receiving any investigational drugs or using any experimental devices in addition to BRV - Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE) - Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) during the study\n- Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Incidence of serious adverse events (SAEs) during the study\n- Incidence of IMP related TEAEs during the study","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
39
Recruitment Window Months
68
Consent Approach
Informed consent and assent processes are used. Participants must provide informed consent/assent as appropriate; for minors the parent/legal representative/caregiver must provide signed informed consent. Multiple country-specific subject information and informed consent form documents (including assent forms and age-specific forms) are provided in local languages (documents available for IT, ES, RO, SK and English versions listed).

Geography

Total Number Of Sites
16
Total Number Of Participants
31

Italy

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
10-03-2025
Processing Time Days
325
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Bambino Gesu Childrens Hospital
Department Name
#40766: UOC Neurologia
Contact Person Name
Nicola Specchio
Contact Person Email
nicola.specchio@opbg.net
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
#40144: UOC Neuropsichiatria Infantile
Contact Person Name
Elena FRERI
Contact Person Email
elena.freri@istituto-besta.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
#40763: UOC Neuropsichiatria Infantile
Contact Person Name
Francesca Darra
Contact Person Email
francesca.darra@univr.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
#40762: Pad B Reparto Neurologia Pediatrica
Contact Person Name
Stefania Maria Bova
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
#40629: UOC Neuropsichiatria Infantile
Contact Person Name
Domenica Immacolata Battaglia
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
#40765: Dipartimento di Neuroscienze
Contact Person Name
Gabriella Di Rosa
Contact Person Email
gdirosa@unime.it
Site Name
Neurological Institute Foundation Casimiro Mondino
Department Name
#40764: Neuropsichiatria Infantile
Contact Person Name
Valentina De Giorgis
Contact Person Email
valentina.degiorgis@mondino.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
#40144: UOC Neuropsichiatria Infantile
Contact Person Name
Elena FRERI
Contact Person Email
elena.freri@istituto-besta.it
Site Name
Bambino Gesu Childrens Hospital
Department Name
#40766: UOC Neurologia
Contact Person Name
Nicola Specchio
Contact Person Email
nicola.specchio@opbg.net

Romania

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
361
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
#40767: Pediatric Neurology
Contact Person Name
Dana Craiu
Contact Person Email
dcraiu@yahoo.com
Site Name
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
Department Name
#40770: Pediatric Neurology
Contact Person Name
Liliana Nussbaum
Contact Person Email
laura_nussbaum@yahoo.com.au
Site Name
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Doctor Nicolae Robanescu
Department Name
#40769: Pediatric Neurology
Contact Person Name
Madalina Leanca
Contact Person Email
Mada_mada332@yahoo.com
Site Name
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi
Department Name
#40768: Pediatric Neurology
Contact Person Name
Ioana Grigore
Contact Person Email
ioanag74@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
338
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
#40453: Neurologia
Contact Person Name
Meritxell Martínez Ferri
Contact Person Email
mmartinezf@mutuaterrassa.es

Slovakia

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
245
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
In Medic s.r.o
Department Name
#40771: Neurology
Contact Person Name
Jana Chamilova
Contact Person Email
jana.chamilova7@gmail.com
Site Name
Konzilium s.r.o.
Department Name
#40772: Neurology
Contact Person Name
Magdalena Perichtova
Contact Person Email
perichtova.md@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Codes: 1,11,12,13,5,6

Third parties

  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Translation Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Codes: 1,11,12,13,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Research Foundation for Mental Hygiene, Inc.","duties_or_roles":"License holder of Columbia – Suicide Severity Rating Scale (C-SSRS)","organisation_type":"Health care"}

Investigational products

Investigational Product Name
brivaracetam (FILM-COATED TABLET, ORAL SOLUTION)
Active Substance
BRIVARACETAM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus=1)
Maximum Dose
200 mg (maxDailyDoseAmount 200 mg)

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