CEREBROLYSIN CONCENTRATE for Traumatic brain injury

Inclusion criteria

• {"criterion_text":"- Diagnosis of TBI and a GCS score of 7-12 (best available score in 24h after hospital admission). Pre-hospital intubation/sedation/paralysis is accepted if the GCS score has been assessed before intubation/sedation/paralysis by trained personnel.\n- A pre-treatment GCS score of 7-12. If intubation/sedation/paralysis occurs after hospital admission, the pre-treatment GCS score has been assessed before intubation/sedation/paralysis.\n- Isolated TBI only (abbreviated injury score (AIS) in other body regions of ≤2)\n- CT (Marshal classification) I to VI (from diffuse injury to non-evacuated mass lesion)\n- Pre-Trauma Karnofsky Index = 100. If no corresponding information is available before the start of treatment (e.g., the patient is unconscious or not able to communicate) and no information is retrieved within 24 hours after the start of treatment, the patient stays in the study. If no information is available before the start of treatment and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.\n- Aged 18-85 years\n- Able to provide written informed consent to enrollment\n- Willing and able to comply with the protocol requirements for the duration of the study\n- Women of child-bearing potential with a negative urine pregnancy test who are willing to practice an acceptable method of birth control\n- Time to needle for study medication should be within 4 hours\n- Patients were able to speak, read and write before the accident. If no corresponding information is available before the start of treatment (e.g., the patient is unconscious or not able to communicate) and if no information is retrieved within 24 hours after the start of treatment, the patient should remain in the study. If no information is available before the start of treatment and if a violation of this inclusion criterion is detected within 24 hours after the start of treatment the patient should be withdrawn from the study, and the treatment medication should be stopped."}

Exclusion criteria

• {"criterion_text":"- Patients with polytrauma (AIS score in other body regions of >2)\n- Patients with spinal cord injury\n- History of intracranial intervention or hemorrhagic stroke\n- Patients who had an ischemic stroke in the 12 months prior to the traumatic brain injury\n- Existence of neurodegenerative diseases\n- Patients who in the investigator’s opinion would not comply with study procedures\n- Patients with a history of epileptic seizure\n- Use of concomitant neuroprotective treatment or cholinesterase inhibitors for previous cognitive treatment\n- Persons who are under chronic treatment (>6 months) with cortisone, Ca+-channel blockers, antidepressants, antipsychotic drugs or nootropic molecules\n- Significant or unstable medical, systemic or logistical condition that affects the subject’s ability to give informed consent or to complete the study procedures"}

Primary endpoints

• {"endpoint_text":"- Glasgow Outcome Scale Extended (GOSE) outcome at 90 days after baseline","definition_or_measurement_approach":"Measurement: Glasgow Outcome Scale Extended (GOSE) assessed at 90 days after baseline"}

Secondary endpoints

• {"endpoint_text":"- efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 10,45, 90 and 180 days after baseline.","definition_or_measurement_approach":"Assessment of neurological deficit, functional outcome, anxiety and depression symptoms, safety and quality of life at days 10, 45, 90 and 180 after baseline comparing Cerebrolysin versus Placebo"}

Romania

Earliest CTIS Part Ii Submission Date

27-06-2024

Latest Decision Or Authorization Date

27-08-2024

Processing Time Days

61

Number Of Sites

1

Number Of Participants

440

Primary sponsor

Full Name

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Romania