Clinical trial • Phase II • Neurology
CENEGERMIN for Traumatic brain injury (subacute, moderate to severe)
Phase II trial of CENEGERMIN for Traumatic brain injury (subacute, moderate to severe).
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Traumatic brain injury (subacute, moderate to severe)
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 05-12-2025
- First CTIS Authorization Date
- 14-04-2026
Trial design
Randomised, vehicle (placebo) - comparator (no dose or schedule specified in the provided data).-controlled, adaptive Phase II trial across 26 sites in Denmark, Finland, France and others.
- Randomised
- Yes
- Comparator
- Vehicle (placebo) - comparator (no dose or schedule specified in the provided data).
- Adaptive
- True (adaptive proof-of-concept, dose-selecting design is stated; specific dose-escalation rules/interim analysis stopping rules not provided in the JSON).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 146
- Trial Duration For Participant
- 365
Eligibility
Recruits 146 Vulnerable population selected: participants with moderate to severe TBI (isVulnerablePopulationSelected = true). The submission includes subject information/ICF and care-partner/proxy consent materials and assent documents (examples: L1_DE_SIS-ICF_Assent_German_redacted; L1_FR_SIS ICF_Care Partner_French_redacted; L1_IT_SIS-ICF_Care partner_Italian_redacted). This indicates consent may be obtained from the participant or, where capacity is impaired, via a care partner/close person or legal representative with assent documentation available..
- Vulnerable Population
- Vulnerable population selected: participants with moderate to severe TBI (isVulnerablePopulationSelected = true). The submission includes subject information/ICF and care-partner/proxy consent materials and assent documents (examples: L1_DE_SIS-ICF_Assent_German_redacted; L1_FR_SIS ICF_Care Partner_French_redacted; L1_IT_SIS-ICF_Care partner_Italian_redacted). This indicates consent may be obtained from the participant or, where capacity is impaired, via a care partner/close person or legal representative with assent documentation available.
Inclusion criteria
- {"criterion_text":"- 1. Male and female adults 18 to 70 years of age.\n- 2. TBI resulting in hospital evaluation within the last 2-8 weeks prior to informed consent\n- 3. A clinical diagnosis of moderate to severe TBI (defined by Glasgow Coma Scale [GCS] score 3 to 12), considering the highest GCS score assessed within 24 hours following injury\n- 4. Confirmed TBI diagnosis by computed tomography (CT) assessed by the investigator\n- 5. Anticipated discharge to a rehabilitation setting within a facility or at home."}
Exclusion criteria
- {"criterion_text":"- 1. GOS-E score of 7 (lower good recovery) or 8 (upper good recovery) at time of informed consent.\n- 2. Penetrating TBI (eg, gunshot, stabs).\n- 3. Medically refractory brain edema at time of screening.\n- 4. Dependence on invasive mechanical ventilation without the ability to sustain spontaneous breathing at time of screening.\n- 5. Poor survival prognosis (investigator assessment).\n- 6. Pre-existing medical conditions which can continue to produce functional disability up to the time of injury."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incidence of treatment-emergent serious and non-serious adverse events through 6 months following the first intranasal administration of cenegermin.","definition_or_measurement_approach":"Incidence (count/proportion) of treatment-emergent serious and non-serious adverse events assessed through 6 months after first intranasal administration of cenegermin."}
Secondary endpoints
- {"endpoint_text":"- 1. Sliding and good outcome in Glasgow Outcome Scale – Extended at month 6.","definition_or_measurement_approach":"GOS-E assessed at month 6 using a sliding dichotomy approach to define a 'good outcome'."}
- {"endpoint_text":"- 2. Through 12 months following the first administration of investigational product.","definition_or_measurement_approach":"Assessments/events measured through 12 months following first administration (broad time window for long-term outcomes/safety)."}
- {"endpoint_text":"- 3. Incidence of treatment-emergent serious and non-serious adverse events, and adverse events of special interest.","definition_or_measurement_approach":"Incidence (count/proportion) of treatment-emergent SAEs, non-serious AEs and AEs of special interest over specified follow-up."}
- {"endpoint_text":"- 4. Participant incidence of study discontinuation for tolerability reasons.","definition_or_measurement_approach":"Proportion/number of participants who discontinue study participation due to tolerability within the study period."}
- {"endpoint_text":"- 5. Change from baseline on vital signs, 12-lead ECG results, clinical laboratory assessments, physical examinations, brain MRI, C-SSRS and blood levels of ADA.","definition_or_measurement_approach":"Change-from-baseline analyses for vital signs, 12-lead ECG, labs, physical exam, brain MRI findings, Columbia-Suicide Severity Rating Scale (C-SSRS) results, and anti-drug antibody (ADA) blood levels."}
Recruitment
- Digital Remote Recruitment
- True (digital microsites and social media banners—Facebook and LinkedIn—are included in country-specific recruitment materials; digital outreach targeted to patients/caregivers in the listed countries).
- Planned Sample Size
- 146
- Recruitment Window Months
- 25
- Consent Approach
- Informed consent obtained using subject information and ICF documents provided in local languages. Materials include main ICFs, assessment ICFs, pregnancy follow-up ICFs and care-partner/close-person ICFs. Assent documents are present for at least Germany and Italian submissions (e.g. L1_DE_SIS-ICF_Assent_German_redacted; L1_IT_SIS-ICF_Privacy and Assent documents). Local-language ICFs and study summaries are provided (Danish, Finnish, French, German, Italian, Spanish, Swedish, Polish). Where participants may lack capacity, care-partner/legal representative materials are provided indicating proxy/representative consent processes.
Methods
- Country-specific recruitment procedures and materials (K1 documents) are provided for Denmark, Finland, France, Germany, Italy, Spain, Sweden and Poland.
- Use of referral letters and healthcare professional referrals (referral letters present in multiple countries).
- Caregiver/close-person outreach (Dear Caregiver letters and Care Partner ICFs present).
- Printed materials: posters and brochures (country-specific K2 recruitment materials).
- Digital channels: microsites and social media banners (Facebook, LinkedIn) present in country-specific K2 materials.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 146
Denmark
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Brain and Spinal Cord Injury, Neuroscience center
- Contact Person Name
- Christina Kruuse
- Contact Person Email
- christina.kruuse@regionh.dk
Finland
- Earliest CTIS Part Ii Submission Date
- 17-03-2026
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- HUS-yhtymae
- Department Name
- Department of Neurology
- Contact Person Name
- Ivan Marinkovic
- Contact Person Email
- ivan.marinkovic@hus.fi
France
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 54
- Number Of Sites
- 2
- Number Of Participants
- 22
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Department of anesthesiology
- Contact Person Name
- Alice Jacquens
- Contact Person Email
- Alice.jacquens@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Physical and rehabilitation Medicine
- Contact Person Name
- Djamel Ben-Smail
- Contact Person Email
- djamel.bensmail@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-03-2026
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 29
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- curiositas ad sanum Studien und Beratungs GmbH
- Contact Person Name
- Johannes Schwarz
- Contact Person Email
- j.schwarz@curiositas-ad-sanum.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Neurochirurgische Klinik
- Contact Person Name
- Charlotte Flueh
- Contact Person Email
- charlotte.flueh@med.uni-goettingen.de
- Site Name
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH
- Department Name
- Neurologie
- Contact Person Name
- Peter Schwenkreis
- Contact Person Email
- studien-neurologie@bergmannsheil.de
- Site Name
- BG Kliniken Ludwigshafen und Tuebingen gGmbH
- Department Name
- Klinik für Neurochirurgie
- Contact Person Name
- Alexander Younsi
- Contact Person Email
- alexander.younsi@bgu-ludwigshafen.de
- Site Name
- BG Klinikum Bergmannstrost Halle gGmbH
- Department Name
- Klinik für Neurochirurgie
- Contact Person Name
- Stefan Bone
- Contact Person Email
- stefan.bone@bergmannstrost.de
- Site Name
- RKH Klinken Ludwigsburg-Bietigheim gGmbH
- Department Name
- Klinik für Neurochirurgie
- Contact Person Name
- Oliver Sakowitz
- Contact Person Email
- oliver.sakowitz@uni-heidelberg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 13-03-2026
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 33
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Della Valle Olona
- Department Name
- Neuroscience department
- Contact Person Name
- Valeria Caso
- Contact Person Email
- valeria.caso@asstvalleona.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- SC Terapia Intensiva e Semi-Intensiva a indirizzo neurologico/neurochirurgico
- Contact Person Name
- Giuseppe Citerio
- Contact Person Email
- giuseppe.citerio@unimib.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Department of Biomedical Sciences
- Contact Person Name
- Alessio Baricich
- Contact Person Email
- alessio.baricich@hunimed.eu
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Terapia Intensiva ad indirizzo neurologico/neurologico
- Contact Person Name
- Arturo Chieregato
- Contact Person Email
- arturo.chieregato@ospedaleniguarda.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOSD Terapia Intensiva Neurochirurgica
- Contact Person Name
- Anselmo Caricato
- Contact Person Email
- anselmo.caricato@policlinicogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 16-03-2026
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 31
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Hospital Universitari Joan XXIII De Tarragona
- Department Name
- Medical Neurosurgery
- Contact Person Name
- Ruth Lau Rodríguez
- Contact Person Email
- slaur.hj23.ics@gencat.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Anaesthesia. Resuscitation and Pain Unit
- Contact Person Name
- Rafael Jose Badenes Quiles
- Contact Person Email
- rafaelbadenes@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Medical Neurosurgery
- Contact Person Name
- José Fernández Alen
- Contact Person Email
- jafalen@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Medical Neurosurgery
- Contact Person Name
- Borja Jesús Hernández García
- Contact Person Email
- borjajhega@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Neurosurgery
- Contact Person Name
- Luis Ley Urzaiz
- Contact Person Email
- luis.ley@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Neurosurgery
- Contact Person Name
- Alfonso Lagares Gomez Abascal
- Contact Person Email
- algadoc@yahoo.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 16-03-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Region Oerebro Laen
- Department Name
- Enheten för Kliniska Studier
- Contact Person Name
- Andras Búki
- Contact Person Email
- Andras.buki@oru.se
Poland
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 18
- Number Of Sites
- 4
- Number Of Participants
- 26
Sites
- Site Name
- Linden Sp. z o.o. sp.k.
- Department Name
- not applicable/nie dotyczy
- Contact Person Name
- Małgorzata Krawczyk
- Contact Person Email
- rejestracja@cmlinden.com
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Rehabilitacji z Pododdziałem Rehabilitacji Neurologicznej
- Contact Person Name
- Katarzyna Gniadek-Olejniczak
- Contact Person Email
- Kgniadek-olejniczak@wim.mil.pl
- Site Name
- Szpital Specjalistyczny Ducha Swietego W Sandomierzu
- Department Name
- Klinika Neurologii z Oddziałem Neurologii i Oddziałem Udarowym UJK w Sandomierzu
- Contact Person Name
- Piotr Sobolewski
- Contact Person Email
- neurologia@sand.pl
- Site Name
- NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
- Department Name
- not applicable/nie dotyczy
- Contact Person Name
- Adrzej Bogucki
- Contact Person Email
- recepcja@neuroklinika.eu
Sponsor
Primary sponsor
- Full Name
- Dompe' Farmaceutici S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Contract research organisation responsibilities noted, including PV, DMC, Patient Recruitment and Retention, Home Nursing, Investigator and patient portals, investigator payment and meetings, Patient re-imbursement, Medical equipment, Central imaging, Global logistics, Translations and printing (as listed in sponsorDuties).
Third parties
- {"country":"Italy","full_name":"Dompe' Farmaceutici S.p.A.","duties_or_roles":"Production of API","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties listed (codes present). Provided duties include: codes 1,10,12 and code 15 with value 'PV, DMC, Patient Recruitment and Retention, Home Nursing, Investigator and patient portals, investigator payment and meetings, Patient re-imbursement, Medical equipment, Central imaging, Global logistics, Translations and printing.', codes 2,4,5,6,7,8.","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BAP Pharma GmbH","duties_or_roles":"Secondary packaging, labelling, release and distribution","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Patheon Italia S.p.A.","duties_or_roles":"Production of rhNGF and placebo","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Arisglobal Limited","duties_or_roles":"Safety database vendor; additional duties codes 2 and 3","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.","duties_or_roles":"Production of diluent","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Cenegermin
- Active Substance
- CENEGERMIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intranasal (INTRANASAL USE)
- Route
- INTRANASAL USE
- Authorisation Status
- prodAuthStatus 1 (product record field)
- Investigational Product Name
- Vehicle
- Modality
- Other
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