Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study

NCT ID: NCT07043686

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2027-10-15

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1: Cerebrolysin Group

The patients in Arm 1 will be treated with cerebrolysin and standard treatment.

Group Type: EXPERIMENTAL

Cerebrolysin treatment

Intervention Type: DRUG

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 stroke

Intervention Type: OTHER

"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.

Arm 2: Standard treatment only Group

The patients in Arm 2 will receive standard treatment only.

Group Type: OTHER

Standard treatment (including neurorehabilitation) of acute ischemic stroke

Intervention Type: OTHER

"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.

Interventions

Cerebrolysin treatment

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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)

-

Exclusion Criteria

Not being able to perform ARAT test

• Previous stroke or disability (mRS > 0)
• The patient unable to understand instructions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Matija Zupan

neurologist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matija Zupan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

UMC Ljubljana - Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT)

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Matija Zupan, MD, PhD

Role: CONTACT

matija.zupan@kclj.si

0038615229581

Marjan Zaletel, MD, PhD

Role: CONTACT

marjan.zaletel@kclj.si

0038615227115

Facility Contacts

Matija Zupan, MD, PhD

Role: primary

matija.zupan@kclj.si

0038615229581

Marjan Zaletel, MD, PhD

Role: backup

marjan.zaletel@kclj.si

0038615227115

References

van den Brule FA, Castronovo V, Menard S, Giavazzi R, Marzola M, Belotti D, Taraboletti G. Expression of the 67 kD laminin receptor in human ovarian carcinomas as defined by a monoclonal antibody, MLuC5. Eur J Cancer. 1996 Aug;32A(9):1598-602. doi: 10.1016/0959-8049(96)00119-0.

Reference Type: BACKGROUND

PMID: 8911124 (View on PubMed)

Other Identifiers

CER-KOVNINT-2025

Identifier Type: -

Identifier Source: org_study_id