Clinical trial • Phase III • Neurology
CENOBAMATE for Primary generalized tonic-clonic seizures
Phase III trial of CENOBAMATE for Primary generalized tonic-clonic seizures. open-label, none/not specified-controlled. 54 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Primary generalized tonic-clonic seizures
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Other
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 18-04-2024
- First CTIS Authorization Date
- 10-05-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Germany, Spain, Hungary and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 54
- Trial Duration For Participant
- 385
Eligibility
Recruits 54 paediatric patients.
- Vulnerable Population
- Includes adolescents (12 to <18 years) and other vulnerable subjects. Written informed consent must be signed by the subject or legal guardian; if the legal guardian provides consent because the subject is unable to, a written or verbal assent from the subject must also be obtained. Country-specific regulations may require that only the subject may sign the ICF. Age-specific assent and ICF documents are provided (e.g. assent 12-17, adult-parent ICF).
Inclusion criteria
- {"criterion_text":"- The subject must have successfully completed the Double-blind Treatment Period in the Core study.\n- Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in accordance with ICH guidelines."}
Exclusion criteria
- {"criterion_text":"- Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.\n- Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study. Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoints are safety measures: the incidences of adverse events (AEs) and serious adverse events (SAEs); summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination, and electrocardiogram (ECG) findings.","definition_or_measurement_approach":"Incidences of AEs and SAEs will be recorded; summary statistics will be produced for clinical laboratory test results and vital signs; findings from physical, neurologic examinations and ECGs will be collected and summarised."}
Secondary endpoints
- {"endpoint_text":"- N/A","definition_or_measurement_approach":"N/A"}
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 89
- Consent Approach
- Written informed consent is required and must be signed by the subject or legal guardian prior to entry. If consent is provided by the legal guardian because the subject is unable, a written or verbal assent from the subject must also be obtained. Age-specific ICFs and assent forms exist (e.g. assent 12-17, adult-parent ICF). Country-specific ICFs and documents are provided in local languages (examples in the submission: Hungarian, Polish, Slovak).
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 77
Germany
- Earliest CTIS Part Ii Submission Date
- 14-05-2024
- Latest Decision Or Authorization Date
- 14-05-2024
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Kinder- und Jugendmedizin II, Abteilung fuer Neuropädiatrie und Sozialpädiatrie
- Principal Investigator Name
- Hiltrud Muhle
- Principal Investigator Email
- Hiltrud.muhle@uksh.de
- Contact Person Name
- Hiltrud Muhle
- Contact Person Email
- Hiltrud.muhle@uksh.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Pediatric Neurology
- Principal Investigator Name
- Angela Kaindl
- Principal Investigator Email
- Neuropaed-studie@charite.de
- Contact Person Name
- Angela Kaindl
- Contact Person Email
- Neuropaed-studie@charite.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Neuropädiatrie
- Principal Investigator Name
- Ralf Husain
- Principal Investigator Email
- Neuropaed@med.uni-jena.de
- Contact Person Name
- Ralf Husain
- Contact Person Email
- Neuropaed@med.uni-jena.de
- Site Name
- Epilepsiezentrum Kleinwachau gGmbH
- Department Name
- Fachklinik für Neurologie
- Principal Investigator Name
- Nils Holert
- Principal Investigator Email
- l.burow@kleinwachau.de
- Contact Person Name
- Nils Holert
- Contact Person Email
- l.burow@kleinwachau.de
Spain
- Earliest CTIS Part Ii Submission Date
- 10-05-2024
- Latest Decision Or Authorization Date
- 10-05-2024
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Patricia Smeyers
- Principal Investigator Email
- nidrasmeyers@gmail.com
- Contact Person Name
- Patricia Smeyers
- Contact Person Email
- nidrasmeyers@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Neurology
- Principal Investigator Name
- Adrián García Ron
- Principal Investigator Email
- drgarciaron@gmail.com
- Contact Person Name
- Adrián García Ron
- Contact Person Email
- drgarciaron@gmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Neurology
- Principal Investigator Name
- Rocio Calvo
- Principal Investigator Email
- rrro@hotmail.com
- Contact Person Name
- Rocio Calvo
- Contact Person Email
- rrro@hotmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 10-05-2024
- Latest Decision Or Authorization Date
- 05-05-2025
- Processing Time Days
- 360
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Semmelweis University
- Department Name
- Gyermekgyógyászati Klinika, Bókay utcai részleg
- Principal Investigator Name
- Márk Kristóf Farkas
- Principal Investigator Email
- kristofm.farkas@gmail.com
- Contact Person Name
- Márk Kristóf Farkas
- Contact Person Email
- kristofm.farkas@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 05-05-2025
- Processing Time Days
- 354
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Niepubliczny Zakład Opieki Zdrowotnej - Centrum Neurologii Dziecięcej i Leczenia Padaczki
- Department Name
- NZOZ, Centrum Neurologii Dziecięcej i Leczenia Padaczki
- Principal Investigator Name
- Anna Gniatkowska-Nowakowska
- Principal Investigator Email
- ankagn@mp.pl
- Contact Person Name
- Anna Gniatkowska-Nowakowska
- Contact Person Email
- ankagn@mp.pl
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Department Name
- Centrum Medyczne Plejady
- Principal Investigator Name
- Marta Żołnowska
- Principal Investigator Email
- trials@plejady.com.pl
- Contact Person Name
- Marta Żołnowska
- Contact Person Email
- trials@plejady.com.pl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 10-05-2024
- Latest Decision Or Authorization Date
- 15-05-2025
- Processing Time Days
- 370
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- Konzilium s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Magdalena Perichtova
- Principal Investigator Email
- konzilium.med@gmail.com
- Contact Person Name
- Magdalena Perichtova
- Contact Person Email
- konzilium.med@gmail.com
- Site Name
- In Medic s.r.o
- Department Name
- Neurology
- Principal Investigator Name
- Jana Chamilova
- Principal Investigator Email
- jana.chamilova7@gmail.com
- Contact Person Name
- Jana Chamilova
- Contact Person Email
- jana.chamilova7@gmail.com
Sponsor
Primary sponsor
- Full Name
- Sk Life Science Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: 1,11,12,2,3,6,7,9; contact CTIS-Biotech@iconplc.com
- Name
- Iqvia Rds Ireland Limited
- Responsibilities
- sponsorDuties codes: 8; contact QPV_SKLSI_RegMailbox@quintiles.com
- Name
- MEDPACE LABORATORIES
- Responsibilities
- sponsorDuties codes: 4; contact RS-Advisor-Support@medpace.com
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,11,12,2,3,6,7,9; contact CTIS-Biotech@iconplc.com","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"Travel reimbursement vendor in Hungary (code:15); contact info@opt-x-pense.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Njs Associates Company","duties_or_roles":"codes: 10; contact leonard.gold@njstat.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Travel reimbursement vendor in Spain (code:15); contact info@scoutclinical.com","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"codes: 14,15; IP QP Release site; contact info-berlin@pci.com","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Iqvia Rds Ireland Limited","duties_or_roles":"codes: 8; contact QPV_SKLSI_RegMailbox@quintiles.com","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"codes: 4; contact RS-Advisor-Support@medpace.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 7; contact helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Cenobamate 12.5mg
- Active Substance
- CENOBAMATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Starting Dose
- Adults: 200 mg/day (Open-label Maintenance Period start); Adolescents: adolescent equivalent based on weight via oral suspension
- Dose Levels
- 12.5 mg tablet strength (also available: 25mg, 50mg, 100mg; oral suspension 10 mg/mL)
- Frequency
- Once daily (200 mg/day starting dose stated for adults)
- Maximum Dose
- 200 mg/day (maxDailyDoseAmount: 200 mg for tablet formulations)
- Investigational Product Name
- Cenobamate 25mg
- Active Substance
- CENOBAMATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Starting Dose
- Adults: 200 mg/day (Open-label Maintenance Period start); Adolescents: adolescent equivalent based on weight via oral suspension
- Dose Levels
- 25 mg tablet strength (also available: 12.5mg, 50mg, 100mg; oral suspension 10 mg/mL)
- Frequency
- Once daily (200 mg/day starting dose stated for adults)
- Maximum Dose
- 200 mg/day
- Investigational Product Name
- Cenobamate 50mg
- Active Substance
- CENOBAMATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Starting Dose
- Adults: 200 mg/day (Open-label Maintenance Period start); Adolescents: adolescent equivalent based on weight via oral suspension
- Dose Levels
- 50 mg tablet strength (also available: 12.5mg, 25mg, 100mg; oral suspension 10 mg/mL)
- Frequency
- Once daily (200 mg/day starting dose stated for adults)
- Maximum Dose
- 200 mg/day
- Investigational Product Name
- Cenobamate 100mg
- Active Substance
- CENOBAMATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Starting Dose
- Adults: 200 mg/day (Open-label Maintenance Period start); Adolescents: adolescent equivalent based on weight via oral suspension
- Dose Levels
- 100 mg tablet strength (also available: 12.5mg, 25mg, 50mg; oral suspension 10 mg/mL)
- Frequency
- Once daily (200 mg/day starting dose stated for adults)
- Maximum Dose
- 200 mg/day
- Investigational Product Name
- Cenobamate 10mg/mL (oral suspension)
- Active Substance
- CENOBAMATE
- Modality
- Small molecule
- Routes Of Administration
- Oral suspension (by weight for adolescents)
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Starting Dose
- Adolescents: adolescent equivalent based on weight via oral suspension; Adults: starting regimen described as 200 mg/day (tablets) for adults
- Dose Levels
- 10 mg/mL oral suspension unit strength
- Frequency
- Once daily (adult equivalent dosing described)
- Maximum Dose
- Max daily dose for suspension expressed as 3 mg/kg/day (maxDailyDoseAmount for suspension: 3 mg/kg)
- Investigational Product Name
- Placebo matching with 12.5mg, 25mg, 50mg, 100mg cenobamate tablets and 10mg/kg cenobamate oral suspension unit strength
- Modality
- Other
- Combination Treatment
- Yes
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