Ischemic Stroke, AcuteNCT07043686
Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study
A study testing Cerebrolysin treatment and Standard treatment (including neurorehabilitation) of acute ischemic stroke in people with Ischemic Stroke, Acute and Rehabilitation Outcome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The study evaluates the effect and safety of Cerebrolysin administered during early rehabilitation in patients with moderate neurological impairment after acute ischemic stroke, conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, UMC Ljubljana. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Rehabilitation Outcome, Cerebrolysin
- What is being tested?
- Cerebrolysin treatment and Standard treatment (including neurorehabilitation) of acute ischemic stroke
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 13 Jun 2025to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being able to perform ARAT test Signed informed consent
- Both sexes, age not specified
- Acute ischemic stroke confirmed by imaging
- NIHSS score 6-12
- No prior stroke or disability (mRS 0 before stroke)
- -
Who cannot join
- Not being able to perform ARAT test
- Previous stroke or disability (mRS > 0)
- The patient unable to understand instructions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana - Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT)
Ljubljana, 1000
Matija Zupan, MD, PhD, 0038615229581, matija.zupan@kclj.si
Marjan Zaletel, MD, PhD, 0038615227115, marjan.zaletel@kclj.si
About this study
Official title: Effect of Cerebrolysin on Early Rehabilitation After Ischemic Stroke at the Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT), University Medical Centre Ljubljana
The study evaluates the effect and safety of Cerebrolysin administered during early rehabilitation in patients with moderate neurological impairment after acute ischemic stroke, conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, UMC Ljubljana.
Read the detailed description
Cerebrolysin is a neuropeptide preparation from porcine brain in an aqueous solution. The composition of 1 ml of the solution contains 215.2 mg of a low molecular weight fraction of polypeptides extracted from porcine brain (Cerebrolysin concentrate), which corresponds to at least 5.8 mg of peptide nitrogen (15%) and free amino acids (85%).
Cerebrolysin has been registered for many years for the treatment of cerebrovascular and neurodegenerative diseases, as well as traumatic brain injuries worldwide. Since the first approval, the treatment of ischemic stroke (IS) has progressed and new treatment concepts have been developed. In addition, the treatment of IS with Cerebrolysin has developed with different time windows, doses and duration of treatment. The main objective of this study is to determine the effectiveness of Cerebrolysin in early rehabilitation as an adjunct to standard treatment in a group of patients with moderate to severe neurological impairment after acute IS in specific KOVNINT conditions.
All patients will receive acute IS care according to local standards of care, which will not be changed or influenced by the study in any way. To assess the safety and efficacy of Cerebrolysin in practice at KOVNINT, the outcome of patients treated with Cerebrolysin will be compared to patients in the control group who will not receive Cerebrolysin.
The reason for conducting the study is to determine the effectiveness of Cerebrolysin treatment in patients with moderate to severe neurological deficits after acute IS at KOVNINT and to assess the impact of these parameters on the outcome of treatment, especially the effect on neurological impairment at discharge and 90 days after IS.
The aim of this study is to observe the safety and efficacy of Cerebrolysin in patients with moderate to severe neurological impairment after acute IS in the specific KOVNINT conditions. We will conduct an analysis of the use of Cerebrolysin as an adjunct to standard treatment and evaluate its efficacy in the early phase of IS, defined by neurological impairment at discharge and 90 days after IS.
Consecutive patients will be enrolled in the study over a specified period, with the investigator independently deciding to treat with Cerebrolysin within 7 days after IS after obtaining informed consent. Patients will be included whose clinical diagnosis of acute IS will be confirmed by imaging, with patients having moderate to severe neurological impairment, defined by an initial NIHSS score of 6-12. All patients will receive standard care for IS according to local treatment. Treatment standards will not be changed and they will not be affected by the study.
Cerebrolysin group: (15 patients) Patients who will be treated with Cerebrolysin will receive the drug according to the SmPC. Dosage 30 ml/day, 10 days. Administration by intravenous infusion (IV infusion). Administration procedure: The drug is diluted to a volume of 100 ml with 0.9% saline. The infusion time will be 15 min.
Patients will receive the drug in accordance with the regulations on sterility of the application. To ensure sterility, single-use infusion sets and cannulas are always used. The infusion is started as soon as possible after dilution.
Control group: (15 patients) Patients receiving all standard care for ICU and not receiving Cerebrolysin.
- Conditions
- Ischemic Stroke, Acute, Rehabilitation Outcome, Cerebrolysin
- Being tested
- Cerebrolysin treatment, Standard treatment (including neurorehabilitation) of acute ischemic stroke
- Keywords
- Cerebrolysin, Acute Ischemic Stroke, Neuroplasticity, Neurorehabilitation, Action Research Arm Test, Slovenia
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrolysin treatmentDrug
The patients will receive Cerebrolysin treatment, 10 days consecutively, 30 ml/day, intravenous infusion diluted up to 100 ml of 0.9% saline in 15 minutes.
Standard treatment (including neurorehabilitation) of acute ischemic strokeOther
"Standard treatment" entails acute ischemic stroke reperfusion treatment according to international guidelines and local policies, instituting secondary preventive treatment, a proper management of stroke risk factors and neurorehabilitation according to patient's needs: locomotor physiotherapy, occupation therapy, speech therapy, and neuropsychological assessment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Cerebrolysin Group | Experimental | The patients in Arm 1 will be treated with cerebrolysin and standard treatment. Receives: Drug: Cerebrolysin treatment; Other: Standard treatment (including neurorehabilitation) of acute ischemic stroke |
| Arm 2: Standard treatment only Group | Other | The patients in Arm 2 will receive standard treatment only. Receives: Other: Standard treatment (including neurorehabilitation) of acute ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Action Research Arm Test (ARAT) Score change
A standardized test after stroke to measure the function of the upper limb. Range of scores: 0-57, with higher scores meaning a better outcome.
Measured: 90 days post-stroke
Secondary outcomes (5)
National Institute of Health Stroke Scale (NIHSS) at discharge and 90 days
NIHSS is standardized in stroke medicine for measuring neurological deficits after stroke; range of scores 0-42, higher scores mean a worse outcome
Measured: 90 days
Modified Rankin Score (mRS) at day 90
mRS is a functional global scale measuring the functional disability after stroke, widely accepted in international registries and trials of stroke, range 0-6, with higher scores meaning worse outcome
Measured: 90 days
Extended Barthel index (EBI) 90 days post-stroke
EBI measures neurological improvement after stroke in activities of daily living, range 0-100, with higher scores meaning better outcome
Measured: 90 days
The De Morton Mobility Index (DEMMI) Score 90 days
Mobility assessment in elderly population, range 0-100, with higher scores meaning a better outcome
Measured: 90 days
Montreal Cognitive Assessment (MoCA) 90 days
MoCA is a screening tool for mild cognitive impairment, range 0-30, with higher scores meaning a better outcome
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start13 Jun 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matija Zupan, University Medical Centre Ljubljana
- Investigators
- Matija Zupan, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043686
- Sponsor's protocol ID
- CER-KOVNINT-2025
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified clinical outcomes data for academic purposes
Publications
Muresanu DF, Livint Popa L, Chira D, Dabala V, Hapca E, Vlad I, Vacaras V, Popescu BO, Chereches R, Strilciuc S, Brainin M. Role and Impact of Cerebrolysin for Ischemic Stroke Care. J Clin Med. 2022 Feb 25;11(5):1273. doi: 10.3390/jcm11051273.
PubMed 35268364
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cerebrolysin on Early Rehabilitation After Ischemic Stroke at the Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT), University Medical Centre Ljubljana
- ClinicalTrials.gov ID
- NCT07043686
- Acronym / sponsor ID
- CER-KOVNINT-2025
- Conditions
- Ischemic Stroke, Acute, Rehabilitation Outcome, Cerebrolysin
- Keywords
- Cerebrolysin, Acute Ischemic Stroke, Neuroplasticity, Neurorehabilitation, Action Research Arm Test, Slovenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the effect and safety of Cerebrolysin administered during early rehabilitation in patients with moderate neurological impairment after acute ischemic stroke, conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, UMC Ljubljana.
Detailed description
Cerebrolysin is a neuropeptide preparation from porcine brain in an aqueous solution. The composition of 1 ml of the solution contains 215.2 mg of a low molecular weight fraction of polypeptides extracted from porcine brain (Cerebrolysin concentrate), which corresponds to at least 5.8 mg of peptide nitrogen (15%) and free amino acids (85%).
Cerebrolysin has been registered for many years for the treatment of cerebrovascular and neurodegenerative diseases, as well as traumatic brain injuries worldwide. Since the first approval, the treatment of ischemic stroke (IS) has progressed and new treatment concepts have been developed. In addition, the treatment of IS with Cerebrolysin has developed with different time windows, doses and duration of treatment. The main objective of this study is to determine the effectiveness of Cerebrolysin in early rehabilitation as an adjunct to standard treatment in a group of patients with moderate to severe neurological impairment after acute IS in specific KOVNINT conditions.
All patients will receive acute IS care according to local standards of care, which will not be changed or influenced by the study in any way. To assess the safety and efficacy of Cerebrolysin in practice at KOVNINT, the outcome of patients treated with Cerebrolysin will be compared to patients in the control group who will not receive Cerebrolysin.
The reason for conducting the study is to determine the effectiveness of Cerebrolysin treatment in patients with moderate to severe neurological deficits after acute IS at KOVNINT and to assess the impact of these parameters on the outcome of treatment, especially the effect on neurological impairment at discharge and 90 days after IS.
The aim of this study is to observe the safety and efficacy of Cerebrolysin in patients with moderate to severe neurological impairment after acute IS in the specific KOVNINT conditions. We will conduct an analysis of the use of Cerebrolysin as an adjunct to standard treatment and evaluate its efficacy in the early phase of IS, defined by neurological impairment at discharge and 90 days after IS.
Consecutive patients will be enrolled in the study over a specified period, with the investigator independently deciding to treat with Cerebrolysin within 7 days after IS after obtaining informed consent. Patients will be included whose clinical diagnosis of acute IS will be confirmed by imaging, with patients having moderate to severe neurological impairment, defined by an initial NIHSS score of 6-12. All patients will receive standard care for IS according to local treatment. Treatment standards will not be changed and they will not be affected by the study.
Cerebrolysin group: (15 patients) Patients who will be treated with Cerebrolysin will receive the drug according to the SmPC. Dosage 30 ml/day, 10 days. Administration by intravenous infusion (IV infusion). Administration procedure: The drug is diluted to a volume of 100 ml with 0.9% saline. The infusion time will be 15 min.
Patients will receive the drug in accordance with the regulations on sterility of the application. To ensure sterility, single-use infusion sets and cannulas are always used. The infusion is started as soon as possible after dilution.
Control group: (15 patients) Patients receiving all standard care for ICU and not receiving Cerebrolysin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Cerebrolysin Group | Experimental | Drug: Cerebrolysin treatment, Other: Standard treatment (including neurorehabilitation) of acute ischemic strokeThe patients in Arm 1 will be treated with cerebrolysin and standard treatment. |
| Arm 2: Standard treatment only Group | Other | Other: Standard treatment (including neurorehabilitation) of acute ischemic strokeThe patients in Arm 2 will receive standard treatment only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being able to perform ARAT test Signed informed consent
- Both sexes, age not specified
- Acute ischemic stroke confirmed by imaging
- NIHSS score 6-12
- No prior stroke or disability (mRS 0 before stroke)
Key exclusion criteria (3 listed)
- Not being able to perform ARAT test
- Previous stroke or disability (mRS > 0)
- The patient unable to understand instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrolysin treatmentThe patients will receive Cerebrolysin treatment, 10 days consecutively, 30 ml/day, intravenous infusion diluted up to 100 ml of 0.9% saline in 15 minutes. | Drug | Arm 1: Cerebrolysin Group |
| Standard treatment (including neurorehabilitation) of acute ischemic stroke"Standard treatment" entails acute ischemic stroke reperfusion treatment according to international guidelines and local policies, instituting secondary preventive treatment, a proper management of stroke risk factors and neurorehabilitation according to patient's needs: locomotor physiotherapy, occupation therapy, speech therapy, and neuropsychological assessment. | Other | Arm 1: Cerebrolysin Group, Arm 2: Standard treatment only Group |
Primary outcome
90-day Action Research Arm Test (ARAT) Score change
Time frame: 90 days post-stroke
A standardized test after stroke to measure the function of the upper limb. Range of scores: 0-57, with higher scores meaning a better outcome.
5 secondary outcomes
National Institute of Health Stroke Scale (NIHSS) at discharge and 90 days
Time frame: 90 days
Modified Rankin Score (mRS) at day 90
Time frame: 90 days
Extended Barthel index (EBI) 90 days post-stroke
Time frame: 90 days
The De Morton Mobility Index (DEMMI) Score 90 days
Time frame: 90 days
Montreal Cognitive Assessment (MoCA) 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 35268364Muresanu DF, Livint Popa L, Chira D, Dabala V, Hapca E, Vlad I, Vacaras V, Popescu BO, Chereches R, Strilciuc S, Brainin M. Role and Impact of Cerebrolysin for Ischemic Stroke Care. J Clin Med. 2022 Feb 25;11(5):1273. doi: 10.3390/jcm11051273.
- Individual participant dataSharing planned: Yes. De-identified clinical outcomes data for academic purposes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matija Zupan, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrolysin treatment and Standard treatment (including neurorehabilitation) of acute ischemic stroke in people with Ischemic Stroke, Acute and Rehabilitation Outcome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matija Zupan, MD, PhD (0038615229581, matija.zupan@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Action Research Arm Test (ARAT) Score change (time frame: 90 days post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07043686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.