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Study of Cerebrolysin to improve arm function in patients recovering from ischemic stroke

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients who have experienced an acute ischemic stroke, a condition where blood flow to part of the brain is blocked. The study will evaluate a medication called Cerebrolysin, which will be given through infusion along with standard stroke treatment. The purpose is to determine if this medication can help improve arm function in patients who have recently had a stroke.

The study will compare Cerebrolysin to placebo, with both being administered through infusion over a period of 21 days. During the treatment, patients will receive either the study medication or placebo mixed with sodium chloride solution. The maximum daily dose of Cerebrolysin will be 30 milliliters.

Patients will be monitored for a total of 90 days to assess how well their arm function improves after the stroke. The study will measure various aspects of recovery, including physical abilities, daily activities, and overall well-being. This is a double-blind study, which means neither the patients nor the healthcare providers will know who receives the actual medication or placebo during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and baseline measurements

    Your eligibility for the study will be assessed based on brain imaging (CT or MRI scan) confirming an ischemic stroke that occurred within the last 72 hours

    Several tests will be performed, including the Action Research Arm Test (ARAT) to measure arm function on the affected side

    Your ability to communicate and your previous level of independence will be evaluated

  2. Step 2

    Treatment phase

    You will receive either Cerebrolysin or a placebo solution through an infusion

    The infusion will be administered alongside your standard stroke treatment

    Neither you nor your doctor will know whether you are receiving Cerebrolysin or placebo

  3. Step 3

    Assessment at day 90

    Your arm function will be measured again using the ARAT test

    Additional assessments will include:

    - Stroke severity scale (NIH Stroke Scale)

    - Level of independence (Modified Rankin Scale)

    - Daily activities performance (Barthel Index)

    - Mood assessment (Hospital Anxiety and Depression Scale)

    - Quality of life questionnaire (EQ-5D-5L)

  4. Step 4

    Study completion

    Final evaluation of your recovery progress

    Documentation of any changes in your condition since the start of the study

    Completion of all required assessments

Who can join the trial?

11 criteria

  • You must be between 18 and 80 years old
  • You must have had an acute ischemic stroke (a type of stroke caused by a blood clot in the brain) in the upper part of the brain, confirmed by CT or MRI scan
  • The stroke must have occurred within the last 72 hours (3 days)
  • The size of the stroke-affected area must be larger than 4 cubic centimeters
  • Your affected arm must score less than 50 points on the ARAT test (a test that measures arm and hand function)
  • You must score higher than 2 points on the Goodglass-Kaplan test (a test that evaluates language and communication abilities)
  • Before the stroke, you must have been fully independent or had very minimal symptoms (scoring 0 or 1 on the modified Rankin Scale, which measures disability)
  • You must not have had another stroke with symptoms in the 3 months before this stroke
  • You must be able to understand the study procedures
  • You must be willing to provide written informed consent
  • You must be eligible to receive standard stroke treatment according to national guidelines

Who cannot join the trial?

15 criteria

  • Previous stroke episodes (damage to the brain due to interrupted blood flow) in the past
  • Severe heart conditions that could affect participation in the study
  • Uncontrolled high blood pressure
  • Active infection or severe inflammatory conditions
  • Current participation in other clinical trials
  • History of severe allergic reactions to medications
  • Severe kidney or liver problems
  • Pregnancy or breastfeeding
  • Unable to follow study instructions or attend follow-up visits
  • Major psychiatric disorders that could interfere with the study
  • Use of medications that could interact with the study treatment
  • Severe cognitive impairment (problems with thinking and memory)
  • Blood clotting disorders
  • Terminal illness with life expectancy less than 90 days
  • History of drug or alcohol abuse within the past 6 months
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Investigated drugs

Cerebrolysin is a brain-specific treatment containing peptides that help support brain function. It is used to help patients recover after a stroke, particularly to improve movement and function in the arms and hands. The medication is given through an injection and works by potentially protecting nerve cells and supporting the brain's natural healing processes after a stroke. It aims to help patients regain better control and movement of their upper limbs following an ischemic stroke (a type of stroke caused by a blood clot in the brain).

What is already known about the treatment

Cerebrolysin - A neuropeptide preparation administered through intravenous injection, consisting of brain-derived peptides and amino acids that has been developed for treating neurological conditions. This medication acts by mimicking the effects of neurotrophic factors, promoting neuronal survival and supporting brain recovery processes, particularly in cases of stroke and other neurological injuries. Cerebrolysin is classified as a neurotrophic agent and has shown promise in post-acute stroke recovery, specifically targeting improvements in upper limb function and overall neurological outcomes. The medication works at the molecular level by stimulating neuroplasticity, protecting neurons from damage, and enhancing neural repair mechanisms in the brain tissue affected by ischemic events.

Investigated diseases

Stroke - A condition that occurs when blood flow to a part of the brain is interrupted, either by a blood clot or a burst blood vessel. It happens suddenly and causes brain cells in the affected area to become damaged due to lack of oxygen and nutrients. The effects of a stroke can include weakness or paralysis on one side of the body, difficulty with speech and language, problems with vision, and changes in sensation. Stroke can affect different parts of the brain, leading to various symptoms depending on which area is damaged. The severity of symptoms depends on the location and extent of brain tissue affected.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521350-41-01Protocol codeFSNANO28012025Estimated enrolment416 patientsSponsorFoundation For The Study Of Nanoneuroscience And Neuroregeneration

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