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Taking people in RomaniaPhase 3

Tests Cerebrolysin for arm recovery after ischemic stroke

Compares Cerebrolysin with placebo in adults recovering from ischemic stroke.

Key facts

Who runs it
Foundation For The Study Of Nanoneuroscience And Neuroregeneration
Where
Cluj-Napoca, RomaniaSee the site
Registry title
A confirmatory study to assess the efficacy of CEREBROLYSIN in post-acute ischemic stroke recovery
Status
Recruiting
Phase
Phase 3
People taking part
416 people, planned
Started
10 Oct 2025
Expected to end
31 Dec 2029
Type of study
Interventional
Record updated
21 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 who recently had an ischemic stroke (a stroke caused by a blocked blood vessel) and still have weak arm function.

Age
18 to 80 years, inclusive
Sex
Men and women
Disease stage
Ischemic stroke above the brainstem, confirmed by CT or MRI, with onset within 72 hours and stroke volume above 4 cm3. Arm function score ARAT below 50 on the affected arm.
Earlier treatment
Must receive standard stroke treatment. Cannot have had Cerebrolysin or neuroprotectants in the last 30 days.
Biomarker or test result
Goodglass-Kaplan score above 2 at baseline. Before the stroke, mRS score of 0 or 1.

Main reasons for not taking part

  • Stroke that is progressing or unstable
  • Another symptomatic stroke within 3 months before baseline
  • Active major neurological or psychiatric disease, such as Parkinson's disease, epilepsy, major depression or dementia
  • Pregnant or breastfeeding women
  • Terminal illness with expected survival under 1 year

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • History of significant alcohol or drug abuse within previous 3 years
  • 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
  • Treatment with Cerebrolysin or Neuroprotectants in the last 30 days
  • Progressive or unstable stroke
  • Any contraindications to Cerebrolysin, including known hypersensitivity to Cerebrolysin or a history of allergic diathesis
  • 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
  • Severe visual or hearing impairment interfering with test procedures
  • Substantial decrease of alertness at randomization
  • Pregnancy or lactating women, or women of childbearing potential who do not agree to use adequate contraception as defined by CTCG guidance
  • Current enrolment in another therapeutic study
  • A terminal medical diagnosis with expected survival < 1 year

Where in Romania

  • Spitalul Clinic Judetean De Urgenta ClujCluj-Napoca, RomaniaTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A confirmatory, randomized, placebo-controlled, double-blind, multicenter trial to assess the efficacy of CEREBROLYSIN in post-acute ischemic stroke recovery (CARS-CT)
Plain-language title
Tests Cerebrolysin for arm recovery after ischemic strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
21 August 2025