CEREBROLYSIN CONCENTRATE for Ischaemic stroke|Stroke

Inclusion criteria

• {"criterion_text":"- Acute ischemic supratentorial stroke confirmed by CT or MRI\n- Patients will receive standard treatment for acute ischemic stroke (AIS) in accordance with national guidelines or standard clinical\n- Onset of stroke within 72 hours\n- Stroke volume of > 4 cm3\n- ARAT score < 50 on the affected arm\n- Goodglass-Kaplan score >2 at baseline\n- Pre-stroke mRS of 0 or 1\n- No symptomatic stroke within 3 months before baseline\n- Age between 18 and 80 years, inclusive\n- Ability to understand the study procedures and willingness to provide written informed consent (ICF)"}

Exclusion criteria

• {"criterion_text":"- Progressive or unstable stroke\n- Substantial decrease of alertness at randomization\n- History of significant alcohol or drug abuse within previous 3 years\n- Pregnancy or lactating women, or women of childbearing potential who do not agree to use adequate contraception as defined by CTCG guidance.\n- 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\n- Any contraindications to Cerebrolysin, including known hypersensitivity to Cerebrolysin or a history of allergic diathesis\n- Current enrolment in another therapeutic study\n- Treatment with Cerebrolysin or Neuroprotectants in the last 30 days\n- Pre-existing and active major neurological disease (eg. Parkinson’s Disease, Epilepsy)\n- Pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia\n- Advanced liver, kidney, cardiac, or pulmonary disease based on the investigator judgement\n- A terminal medical diagnosis with expected survival < 1 year\n- Severe visual or hearing impairment interfering with test procedures"}

Primary endpoints

• {"endpoint_text":"- Action Reasearch Arm Test (ARAT)","definition_or_measurement_approach":"Change of the ARAT Score from baseline to day 90 (assess improvement of upper limb function from baseline to day 90)."}

Secondary endpoints

• {"endpoint_text":"- NIH Stroke Scale (NIH)","definition_or_measurement_approach":"Assessment of neurological deficit measured by NIH Stroke Scale at 7, 14, 21, and 90 days after baseline."}
• {"endpoint_text":"- Modified Rankin Scale (mRS)","definition_or_measurement_approach":"Assessment of functional outcome measured by mRS at 7, 14, 21, and 90 days after baseline."}
• {"endpoint_text":"- Barthel Index","definition_or_measurement_approach":"Assessment of activities of daily living measured by Barthel Index at 7, 14, 21, and 90 days after baseline."}
• {"endpoint_text":"- Hospital Anxiety and Depression Scale (HADS)","definition_or_measurement_approach":"Assessment of symptoms of anxiety and depression using HADS at 7, 14, 21, and 90 days after baseline."}
• {"endpoint_text":"- EQ-5D-5L","definition_or_measurement_approach":"Assessment of quality of life using EQ-5D-5L at 7, 14, 21, and 90 days after baseline."}

Romania

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

21-08-2025

Processing Time Days

140

Number Of Sites

1

Number Of Participants

416

Primary sponsor

Full Name

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Romania

Third parties

• {"country":"Romania","full_name":"Foundation For The Study Of Nanoneuroscience And Neuroregeneration","duties_or_roles":"1","organisation_type":"Laboratory/Research/Testing facility"}