A confirmatory study to assess the efficacy of CEREBROLYSIN in post-acute ischemic stroke recovery

Prior treatment

• 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

Other illness

• 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

Other

• 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

• 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)