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Study on the Effects of Cerebrolysin and Sodium Chloride for Recovery in Patients with Moderate to Severe Traumatic Brain Injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Cerebrolysin for individuals who have experienced a traumatic brain injury, which is a type of injury that occurs when an external force injures the brain. The treatment being tested is a solution that is given through an injection or infusion. In this study, some participants will receive Cerebrolysin, while others will receive a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the effectiveness and safety of Cerebrolysin in helping with recovery after a moderate to severe traumatic brain injury. Participants in the study will be monitored over a period of time to assess their recovery and any changes in their condition. The study will look at various outcomes, including the participants' neurological function, symptoms of anxiety and depression, and overall quality of life at different points in time, such as 10, 45, 90, and 180 days after starting the treatment.

Throughout the study, participants will receive regular assessments to track their progress and any side effects they may experience. The main goal is to determine how well Cerebrolysin works in improving recovery and to ensure it is safe for use in people with traumatic brain injuries. This research aims to provide valuable information that could help improve treatment options for individuals affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, the patient is assessed to confirm eligibility. This includes a diagnosis of traumatic brain injury (TBI) with a Glasgow Coma Scale (GCS) score between 7 and 12, assessed within 24 hours after hospital admission.

    The patient must be aged between 18 and 85 years and able to provide written informed consent. Women of child-bearing potential must have a negative pregnancy test and agree to use birth control.

  2. Step 2

    Initial treatment

    The study medication, Cerebrolysin, is administered within 4 hours of hospital admission. It is given as a solution for injection or infusion, which is a method of delivering medication directly into the bloodstream.

  3. Step 3

    Treatment phase

    The patient receives Cerebrolysin or a placebo. The treatment aims to support neurorecovery after moderate to severe TBI.

    The frequency and dosage of the medication are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Follow-up assessments

    The patient's recovery is monitored using the Glasgow Outcome Scale Extended (GOSE) at 90 days after the start of the study.

    Additional assessments are conducted at 10, 45, 90, and 180 days to evaluate neurological deficits, functional outcomes, symptoms of anxiety and depression, drug safety, and quality of life.

  5. Step 5

    Study completion

    The study is expected to conclude by December 31, 2025. The final outcomes will be analyzed to determine the efficacy and safety of Cerebrolysin in treating TBI.

Who can join the trial?

11 criteria

  • Must have a diagnosis of **traumatic brain injury (TBI)** with a **Glasgow Coma Scale (GCS)** score between 7 and 12. The GCS is a scale used to measure a person's level of consciousness after a brain injury.
  • Pre-hospital procedures like intubation (inserting a tube to help with breathing), sedation (calming the patient with medication), or paralysis (using medication to relax muscles) are allowed if the GCS score was checked before these procedures by trained staff.
  • Only have a **traumatic brain injury** with no significant injuries in other body areas.
  • CT scan results should be classified from I to VI, which ranges from mild brain injury to a non-evacuated mass lesion (a collection of blood or tissue that hasn't been removed).
  • Have a **Karnofsky Index** of 100 before the injury. This index measures a person's ability to perform daily activities, with 100 being fully active.
  • Be between 18 and 85 years old.
  • Must be able to provide written consent to join the study.
  • Willing and able to follow the study's requirements for its entire duration.
  • Women who can have children must have a negative pregnancy test and agree to use birth control.
  • The study medication should be given within 4 hours of the injury.
  • Must have been able to speak, read, and write before the injury. If this information isn't available before treatment and isn't found within 24 hours after starting treatment, the patient can stay in the study. If it's found that this wasn't true within 24 hours, the patient will be removed from the study.

Who cannot join the trial?

4 criteria

  • Patients who have a **traumatic brain injury** cannot participate. This means any injury to the brain caused by an external force, like a fall or accident.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for specific age groups.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Patients who are part of a vulnerable population, which means groups that might need special protection, are not included in this study.
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Investigated drugs

Cerebrolysin is a medication used in this clinical trial to help with recovery after a moderate to severe traumatic brain injury. It is believed to support brain function and improve outcomes by promoting nerve cell repair and growth. The trial aims to evaluate its effectiveness and safety in improving recovery outcomes for patients who have suffered such injuries.

What is already known about the treatment

Cerebrolysin – Cerebrolysin is administered through intravenous infusion and is currently being studied for its effectiveness in aiding recovery after moderate to severe traumatic brain injury. It is recognized in medical literature as a potential treatment for improving neurological outcomes in such conditions. The main therapeutic indication for Cerebrolysin is to support neurorecovery following traumatic brain injuries. At the molecular level, it is believed to work by promoting neuroprotection and neuroplasticity, enhancing the brain's ability to repair and regenerate. Pharmacologically, Cerebrolysin is classified as a neurotrophic agent, which means it supports the growth and survival of neurons.

Investigated diseases

Traumatic Brain Injury – Traumatic brain injury (TBI) occurs when an external force injures the brain, often resulting from falls, vehicle accidents, or sports injuries. The severity of TBI can range from mild, with temporary symptoms, to severe, with long-lasting effects. Symptoms may include headaches, confusion, dizziness, memory problems, and changes in mood or behavior. As the injury progresses, individuals may experience difficulties with concentration, coordination, and communication. In severe cases, TBI can lead to significant physical and cognitive impairments. Recovery varies widely, depending on the extent of the injury and the individual's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515591-12-00Protocol codeC-RETURNEstimated enrolment440 patientsSponsorFoundation For The Study Of Nanoneuroscience And Neuroregeneration

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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