A confirmatory study to assess the efficacy of CEREBROLYSIN in post-acute ischemic stroke recovery
Key facts
- Where
- Cluj-Napoca, RomániaSee the site
- Phase
- 3. fázis
Where in Románia
- Spitalul Clinic Judetean De Urgenta ClujCluj-Napoca, RomániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Foundation For The Study Of Nanoneuroscience And Neuroregeneration
- Trial code
- EU 2025-521350-41-01
- Record updated
- 2025. augusztus 21.
- Original description
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 90Read full original descriptionShow less
A confirmatory, randomized, placebo-controlled, double-blind, multicenter trial to assess the efficacy of CEREBROLYSIN in post-acute ischemic stroke recovery (CARS-CT)
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
Inclusion: 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).
Exclusion: 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.