Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
416
Countries
1
Sites
1
Stroke
To assess the efficacy of Cerebrolysin versus Placebo on the improvement of the upper limb function as evidenced by the change of the ARAT Score from baseline to day 90
Key facts
- Sponsor
- Foundation For The Study Of Nanoneuroscience And Neuroregeneration
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 10 Oct 2025 → ongoing
- Decision date (initial)
- 2025-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of Cerebrolysin versus Placebo on the improvement of the upper limb function as evidenced by the change of the ARAT Score from baseline to day 90
Secondary objectives 2
- To assess the efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, quality of life at 7, 14, 21, and 90 days after baseline..
- To assess the efficacy of Cerebrolysin versus Placebo on the improvement of the upper limb function at 7, 14, and 21 days after baseline.
Conditions and MedDRA coding
Stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | PT | 10061256 | Ischaemic stroke | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomized, placebo-controlled, double-blind This study will be conducted in a double-blind manner to maintain confidentiality of treatment allocation from the Investigators, other study team members, and patients. Cerebrolysin is a brown-colored solution; therefore, colored infusion lines and a covered infusion bag will be used for treatment administration.
|
Randomised Controlled | Double | [{"id":141811,"code":1,"name":"Subject"},{"id":141812,"code":2,"name":"Investigator"},{"id":141813,"code":3,"name":"Monitor"}] |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521350-41-00 | A confirmatory, randomized, placebo-controlled, double-blind, multicenter trial to assess the efficacy of CEREBROLYSIN in post-stroke recovery (CARS-CT) | Foundation For The Study Of Nanoneuroscience And Neuroregeneration |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Acute ischemic supratentorial stroke confirmed by CT or MRI
- Onset of stroke within 72 hours
- Stroke volume of > 4 cm3
- ARAT score < 50 on the affected arm
- Goodglass-Kaplan score >2 at baseline
- Pre-stroke mRS of 0 or 1
- No symptomatic stroke within 3 months before baseline
- Age between 18 and 80 years, inclusive
- Ability to understand the study procedures and willingness to provide written informed consent (ICF)
- Patients will receive standard treatment for acute ischemic stroke (AIS) in accordance with national guidelines or standard clinical
Exclusion criteria 13
- Progressive or unstable stroke
- Any contraindications to Cerebrolysin, including known hypersensitivity to Cerebrolysin or a history of allergic diathesis
- Current enrolment in another therapeutic study
- Treatment with Cerebrolysin or Neuroprotectants in the last 30 days
- Pre-existing and active major neurological disease (eg. Parkinson’s Disease, Epilepsy)
- Pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- Advanced liver, kidney, cardiac, or pulmonary disease based on the investigator judgement
- A terminal medical diagnosis with expected survival < 1 year
- Severe visual or hearing impairment interfering with test procedures
- Substantial decrease of alertness at randomization
- History of significant alcohol or drug abuse within previous 3 years
- Pregnancy or lactating women, or women of childbearing potential who do not agree to use adequate contraception as defined by CTCG guidance.
- Use of concomitant neuroprotective or nootropic medications (e.g., citicoline, memantine, amantadine, erythropoietin, piracetam, pramiracetam, pyritinol,meclosulfonate, or investigational neuroprotective substances) and/or vasodilatory agents affecting cerebral blood flow (e.g., naftidrofuryl, cinnarizine, flunarizine, nimodipine, nicergoline, pentoxifylline, dihydroergotoxine, vinpocetine, vincamine, or ginkgo biloba), except for peripherally acting agent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Action Reasearch Arm Test (ARAT)
Secondary endpoints 5
- NIH Stroke Scale (NIH)
- Modified Rankin Scale (mRS)
- Barthel Index
- Hospital Anxiety and Depression Scale (HADS)
- EQ-5D-5L
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD526503 · Product
- Active substance
- Cerebrolysin Concentrate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 ml millilitre(s)
- Max total dose
- 630 ml millilitre(s)
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- N07XX — OTHER NERVOUS SYSTEM DRUGS
- Marketing authorisation
- 4610/2004/03
- MA holder
- EVER NEURO PHARMA GMBH
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Ser fiziologic 90 mg/10 ml solvent pentru uz parenteral
PRD6672357 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- INFUSION
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 5250 mm millimeter(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 11175/2018/01
- MA holder
- ZENTIVA S.A.
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Foundation For The Study Of Nanoneuroscience And Neuroregeneration
- Sponsor organisation
- Foundation For The Study Of Nanoneuroscience And Neuroregeneration
- Address
- Strada Eliade Mircea No 37
- City
- Cluj-Napoca
- Postcode
- 400354
- Country
- Romania
Scientific contact point
- Organisation
- Foundation For The Study Of Nanoneuroscience And Neuroregeneration
- Contact name
- Muresanu Dafin Fior
Public contact point
- Organisation
- Foundation For The Study Of Nanoneuroscience And Neuroregeneration
- Contact name
- Muresanu Dafin Fior
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Foundation For The Study Of Nanoneuroscience And Neuroregeneration ORG-100051677
|
Cluj-Napoca, Romania | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ongoing, recruiting | 416 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Spitalul Clinic Judetean De Urgenta Cluj
Neurology II, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Romania | 2025-10-10 | 2025-10-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol FSNANO280125 | 3.0 |
| Protocol (for publication) | D1_Protocol FSNANO280125 Track changes | 1 |
| Protocol (for publication) | D4_Patient BARTHEL INDEX | 1 |
| Protocol (for publication) | D4_Patient EQ-5D-5L questionnaire | 1 |
| Protocol (for publication) | D4_Patient Hospital Anxiety and Depression Scale | 1 |
| Protocol (for publication) | D4_Patient mRS scale | 1 |
| Protocol (for publication) | D4_Patient NIH Stroke Scale | 1 |
| Protocol (for publication) | D4_Sumar instrumente de evaluare a pacientilor FSNANO280125 | 1 |
| Recruitment arrangements (for publication) | K1_Procedura de recrutare | 2 |
| Subject information and informed consent form (for publication) | L1_ICF English | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF English Ver1 2 Track changes | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Romanian | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Romanian Ver 1 2 Track changes | 1.2 |
| Subject information and informed consent form (for publication) | L1_Patient EQ-5D-5L questionnaire | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cerebrolysin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis lay-person Romanian language FSNANO280125 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis scientific Romanian language FSNANO280125 | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-14 | Romania | Acceptable with conditions 2025-06-30
|
2025-07-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-21 | Romania | Acceptable with conditions 2025-06-30
|
2025-08-21 |