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    Summary
    EudraCT Number:2022-003382-38
    Sponsor's Protocol Code Number:FSNANO05012022
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-06-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2022-003382-38
    A.3Full title of the trial
    Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury
    Eficacitatea și inocuitatea Cerebrolysin pentru neurorecuperare după traumatism cerebral moderat-sever
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is Cerebrolysin efficient in neurorecovery after moderate-severe traumatic brain injury?
    Este Cerebrolysin eficient in neurorecuperare după traumatism cerebral moderat-sever?
    A.3.2Name or abbreviated title of the trial where available
    C-RETURN
    C-RETURN
    A.4.1Sponsor's protocol code numberFSNANO05012022
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFSNANO05012022
    B.1.3.4CountryRomania
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii
    B.4.2CountryRomania
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii
    B.5.2Functional name of contact pointFSNN
    B.5.3 Address:
    B.5.3.1Street AddressNo. 37 Mircea Eliade Street
    B.5.3.2Town/ cityCluj-Napoca
    B.5.3.3Post code400364
    B.5.3.4CountryRomania
    B.5.4Telephone number+40744844000
    B.5.6E-mailancam@ssnn.ro
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cerebrolysin
    D.2.1.1.2Name of the Marketing Authorisation holderEver Neuro Pharma GMBH, Unterach, Austria
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCerebrolysin
    D.3.2Product code N07XXN3
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboInfusion (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-severe traumatic brain injury
    Traumatism cerebral moderat-sever
    E.1.1.1Medical condition in easily understood language
    Brain injury
    Traumatism cerebral
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 26.1
    E.1.2Level LLT
    E.1.2Classification code 10060690
    E.1.2Term Traumatic brain injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess GOSE outcomes at 90 days after baseline
    Evaluarea rezultatelor pe scala Glasgow Outcome Scale Extended (GOSE) la 90 de zile de la debut.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 30, 90 and 180 days after baseline
    Evaluarea eficacității Cerebrolysin versus Placebo asupra deficitului neurologic, rezultatelor funcționale, simptomelor de anxietate și depresie, siguranței tratamentului și asupra calității vieții la 30, 90 și 180 de zile după inițiere.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Diagnosis of TBI and a GCS score of 7-12 (best available score in 24h after hospital admission). Pre-hospital intubation/sedation/paralysis is accepted if the GCS score has been assessed before intubation/sedation/paralyses by trained personnel.
    ● Pre-treatment GCS score of 7-12. If intubation/sedation/paralysis occurs after hospital admission, the pre-treatment GCS score has been assessed before intubation/sedation/paralyses.
    ● Isolated TBI only (abbreviated injury score (AIS) in other body regions of ≤2)
    ● CT (Marshal classification) I to VI (from diffuse injury to non-evacuated mass lesion)
    ● Pre-Trauma Karnofsky Index = 100. If no corresponding information is available before the start of treatment (e.g., patient is unconscious or not able to communicate) and no information is retrieved within 24 hours after the start of treatment, the patient stays in the study. If no information is available before the start of treatment and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.
    ● Aged 18-85 years
    ● Able to provide written informed consent to enrollment
    ● Willing and able to comply with the protocol requirements for the duration of the study
    ● Women of child-bearing potential with a negative urine pregnancy test who are willing to practice an acceptable method of birth control
    ● Time to needle for study medication should be within 12 hours
    ● Patients were able to speak, read and write before the accident. If no corresponding information is available before the start of treatment (e.g., patient is unconscious or not able to communicate) and if no information is retrieved within 24 hours after the start of treatment, the patient should remain in the study. If no information is available before the start of treatment and if a violation of this inclusion criterion is detected within 24 hours after the start of treatment, the patient should be withdrawn from the study, and the treatment medication should be stopped.
    ● Diagnostic de traumatism cerebral și scor GCS de 7-12 (cel mai bun scor disponibil la 24 de ore după internare). Intubarea/sedarea/paralizia pre-spital este acceptată dacă scorul GCS a fost calculat de personal calificat înainte de intubare/sedare/paralizie.
    ● Scor GCS 7-12 pre-tratament. Dacă intubarea/sedarea/paralizia survine după internare, scorul GCS pre-tratament a fost calculat înainte de intubare/sedare/paralizie.
    ● Traumatism cerebral izolat (scor AIS ≤2 în celelalte părți ale corpului).
    ● Clasificare Marshall a computerului tomograf de la I la VI (de la injurie difuză la leziune de masă neevacuată).
    ● Index Karnofsky înainte de traumă = 100. Dacă aceste informații nu pot fi obținute înainte de începerea tratamentului (e.g., pacientul este inconștient sau nu este capabil de a comunica) și nu sunt obținute în 24 de ore de la începerea tratamentului, pacientul rămâne în studiu. Dacă aceste informații nu sunt obținute înainte de începerea tratamentului și este detectată o încălcare a acestui criteriu de includere în 24 de ore de la începerea tratamentului, pacientul este retras din studiu, iar tratamentul este oprit.
    ● Vârsta de 18-85 ani.
    ● Pacient capabil de a-și oferi consimțământul informat scris pentru înrolare.
    ● Pacient care dorește și este capabil să se conformeze cerințelor protocolului pe durata studiului.
    ● Femei care au potențialul de a rămâne însărcinate, care au test urinar de sarcină negativ și care doresc să utilizeze metode contraceptive potrivite.
    ● Durata “time to needle” pentru medicamentul studiat ar trebui să fie până la 12 ore.
    ● Pacient capabil să vorbească, să citească și să scrie înainte de traumatism. Dacă aceste informații nu pot fi obținute înainte de începerea tratamentului (e.g., pacientul este inconștient sau nu este capabil de a comunica) și nu sunt obținute în 24 de ore de la începerea tratamentului, pacientul rămâne în studiu. Dacă aceste informații nu sunt obținute înainte de începerea tratamentului și este detectată o încălcare a acestui criteriu de includere în 24 de ore de la începerea tratamentului, pacientul este retras din studiu, iar tratamentul este oprit.
    E.4Principal exclusion criteria
    ● Patients with polytrauma (AIS score in other body regions of >2)
    ● Patients with spinal cord injury
    ● History of intracranial intervention or ischemic or hemorrhagic stroke
    ● Existence of psychiatric disorders or neurodegenerative diseases
    ● Patients who in the investigator’s opinion would not comply with study procedures
    ● Patients with a history of epileptic seizure
    ● Use of concomitant neuroprotective treatment or cholinesterase inhibitors for previous cognitive treatment
    ● Persons who are under chronic treatment with cortisone, Ca+-channel blockers, antidepressants (unstable treatment), antipsychotic drugs or nootropic molecules
    ● Significant or unstable medical, systemic or logistical condition that affects the subject’s ability to give informed consent or to complete the study procedures
    ● Pacient cu politraumatisme (scor AIS >2 în alte părți ale corpului).
    ● Pacient cu leziuni ale măduvei spinării.
    ● Istoric de intervenție chirurgicală intracraniană sau accident vascular cerebral hemoragic.
    ● Pacient care a suferit un accident vascular cerebral ischemic în cele 12 luni dinaintea traumatismului cerebral.
    ● Existența unor boli neurodegenerative.
    ● Pacient care, în opinia Investigatorului, nu s-ar conforma procedurilor studiului.
    ● Pacient cu istoric de crize epileptice.
    ● Utilizarea concomitentă de tratament neuroprotectiv sau a inhibitorilor de colinesterază pentru tratament cognitiv precedent.
    ● Pacient aflat sub tratament cronic (>6 luni) cu cortizon, blocanți ai canalelor de calciu, antidepresive (tratament instabil), antipsihotice sau molecule nootrope.
    ● Afecțiune medicală semnificativă, instabilă sau sistemică, care afectează capacitatea subiectului de a-și oferi consimțământul informat sau de a se conforma procedurilor studiului.
    E.5 End points
    E.5.1Primary end point(s)
    The following psychometric tests are included in the primary multivariate analysis (combined cognitive outcome measures): Glasgow Outcome Scale Extended (GOSE)
    Următoarele teste psihometrice sunt incluse în analiza multivariată primară (măsurători cognitive combinate): Glasgow Outcome Scale Extended (GOSE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days after baseline
    90 zile de la baseline
    E.5.2Secondary end point(s)
    Secondary Variables
    Early Rehabilitation Barthel Index (ERBI)
    Mini-Mental State Examination (MMSE)
    Stroop Color-Word Test – Victoria Version (SCW)
    Hospital Anxiety and Depression Scale (HADS)
    Processing Speed Index (PSI)
    Color Trails Test (CTT)
    Digit Span Forward and Backward (DS)
    EQ-5D-5L
    Patient pathway and cost questionnaire
    Safety Variables:
    Deaths
    Adverse Events (AE)
    Severe Adverse Events (SAE)
    Non-Fatal Serious Adverse Events (NF-SAE)
    Variabile secundare
    Early Rehabilitation Barthel Index (ERBI)
    Mini-Mental State Examination (MMSE)
    Stroop Color-Word Test – Victoria Version (SCW)
    Hospital Anxiety and Depression Scale (HADS)
    Processing Speed Index (PSI)
    Color Trails Test (CTT)
    Digit Span Forward and Backward (DS)
    EQ-5D-5L
    Chestionar pentru traseul pacientului și costuri
    Variabile legate de siguranță:
    Decese
    Evenimente adverse (AE)
    Evenimente adverse severe (SAE)
    Evenimente adverse severe nefatale (NF-SAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30,90 and 180 days after baseline
    30,90 si 180 zile de la baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject undergoing the trial.
    Ultima vizita a ultimului pacient efectuata in studiu clinic
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent from traumatic brain injury patients will be obtained from the patient as soon as he regains consciousness.
    Consimtamtul de la pacientii cu traumatism cerebral moderat-sever va fi obtinut de la pacient imediat ce isi recapata starea de constienta
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state440
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nici unul
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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