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A confirmatory study to assess the efficacy of CEREBROLYSIN in post-acute ischemic stroke recovery
EU CTIS ID: 2025-521350-41-01
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Acute ischemic supratentorial stroke confirmed by CT or MRI
- Patients will receive standard treatment for acute ischemic stroke (AIS) in accordance with national guidelines or standard clinical
- Onset of stroke within 72 hours
- Stroke volume of > 4 cm3
- ARAT score < 50 on the affected arm
- Goodglass-Kaplan score >2 at baseline
You likely can't join if
- Progressive or unstable stroke
- 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
- Any contraindications to Cerebrolysin, including known hypersensitivity to Cerebrolysin or a history of allergic diathesis
See the full eligibility criteria
- Acute ischemic supratentorial stroke confirmed by CT or MRI
- Patients will receive standard treatment for acute ischemic stroke (AIS) in accordance with national guidelines or standard clinical
- 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)
- Progressive or unstable stroke
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.