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Cerebrolysin Concentrate

Cerebrolysin Concentrate, a drug derived from brain proteins, is currently being studied in clinical trials for its potential benefits in treating various neurological conditions. These trials aim to assess the safety and efficacy of Cerebrolysin in patients with specific brain disorders, such as CADASIL and traumatic brain injury. The research focuses on evaluating the drug’s impact on cognitive function, mood, and overall recovery in affected individuals.

Table of Contents

What is Cerebrolysin?

Cerebrolysin is a neuropeptide preparation used as a medication to treat various neurological conditions[1]. It is derived from purified brain proteins and contains active fragments of important neurotrophic factors. Cerebrolysin is classified under “Other Nervous System Drugs” and is available as a solution for injection or infusion[2].

Medical Conditions Treated

Cerebrolysin is being studied and used for several neurological conditions, including:

  • CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy): A rare genetic disorder affecting blood vessels in the brain[1].
  • Traumatic Brain Injury (TBI): Injuries to the brain caused by external forces, ranging from moderate to severe[2].

These conditions can significantly impact a person’s cognitive abilities, mood, and overall quality of life. Cerebrolysin is being investigated as a potential treatment to improve outcomes for patients with these challenging neurological disorders.

How Cerebrolysin Works

Cerebrolysin is believed to work by:

  • Promoting neuroprotection: Helping to protect existing brain cells from damage.
  • Enhancing neuroplasticity: Supporting the brain’s ability to form new connections and adapt.
  • Stimulating neurogenesis: Potentially encouraging the growth of new brain cells.

These mechanisms may help improve cognitive function, reduce neurological deficits, and support overall brain health in patients with various neurological conditions[1][2].

Administration and Dosage

Cerebrolysin is typically administered through intravenous infusion or injection. The dosage and duration of treatment can vary depending on the specific condition being treated:

  • For CADASIL patients, the maximum daily dose may be up to 40 ml, with a total treatment period of up to 12 months[1].
  • In traumatic brain injury cases, the maximum daily dose might be 10 ml, with a treatment period of up to 6 weeks[2].

It’s important to note that dosages should always be determined and administered by healthcare professionals based on individual patient needs and conditions.

Ongoing Research

Cerebrolysin is currently being studied in clinical trials to further evaluate its efficacy and safety:

  • The CERICA trial is investigating Cerebrolysin’s effects on patients with genetically proven CADASIL[1].
  • Another study is examining Cerebrolysin’s potential for neurorecovery after moderate to severe traumatic brain injury[2].

These trials aim to assess various outcomes, including cognitive function, mood, imaging characteristics, and overall quality of life for patients receiving Cerebrolysin treatment.

Eligibility for Treatment

Eligibility for Cerebrolysin treatment may vary depending on the specific condition and ongoing clinical trials. Generally, patients must meet certain criteria, such as:

  • Age requirements (typically 18 years or older)
  • Confirmed diagnosis of the target condition (e.g., CADASIL or traumatic brain injury)
  • Absence of certain other neurological or psychiatric conditions
  • No history of substance abuse or severe psychiatric disorders
  • Adequate kidney function

It’s crucial to consult with a healthcare provider to determine if Cerebrolysin is an appropriate treatment option based on individual circumstances[1][2].

Potential Side Effects and Precautions

While Cerebrolysin is generally considered safe, there are some potential side effects and precautions to be aware of:

  • Contraindications: Cerebrolysin should not be used in patients with epilepsy, severe kidney problems, or hypersensitivity to any of its components[1].
  • Pregnancy and breastfeeding: Women of childbearing potential should use adequate contraception methods during treatment[1][2].
  • Drug interactions: Cerebrolysin may interact with other medications, particularly those affecting the nervous system. It’s important to inform your healthcare provider about all medications you are taking[1][2].

As with any medication, it’s essential to discuss potential risks and benefits with your healthcare provider before starting treatment with Cerebrolysin.

Aspect CADASIL Trial Traumatic Brain Injury Trial
Condition Studied CADASIL Moderate to severe traumatic brain injury
Main Objective Global risk-benefit assessment of Cerebrolysin vs. Placebo Assess GOSE outcomes at 90 days after baseline
Study Design Randomized, double-blind, single-centre, two-period cross-over, placebo-controlled Not specified in detail
Primary Endpoints Cognition, mood, imaging characteristics GOSE outcome at 90 days
Secondary Endpoints Not specified Neurological deficit, functional outcome, anxiety and depression symptoms, drug safety, quality of life
Key Inclusion Criteria ≥18 years, genetically proven CADASIL 18-85 years, GCS score 7-12, isolated TBI
Key Exclusion Criteria Other significant neurological diseases, severe psychiatric disorders Polytrauma, spinal cord injury, history of intracranial intervention or hemorrhagic stroke
Drug Administration Intravenous infusion, max 40 ml daily, up to 1920 ml total Parenteral use, max 10 ml daily, up to 50 ml total
Treatment Duration Up to 12 months Up to 6 weeks

FAQ

  • What is Cerebrolysin Concentrate? Cerebrolysin Concentrate is a drug derived from brain proteins that is being studied for its potential benefits in treating various neurological conditions. It is administered as a solution for injection or infusion.
  • What conditions are being studied in these clinical trials? The clinical trials are focusing on two main conditions: CADASIL (Cerebral Autosomal Dominant Arteriopathy with subcortical Infarcts and Leukoencephalopathy) and moderate to severe traumatic brain injury.
  • How is Cerebrolysin administered in these trials? In the trials, Cerebrolysin is administered through intravenous infusion or parenteral use. The dosage and duration of treatment vary depending on the specific trial and condition being studied.
  • What are the main objectives of these clinical trials? The main objectives include assessing the safety and efficacy of Cerebrolysin compared to placebo, evaluating its impact on cognitive function, mood, and imaging characteristics in CADASIL patients, and measuring recovery outcomes in patients with traumatic brain injury.
  • Who can participate in these clinical trials? Eligibility criteria vary between trials, but generally include adult patients (18-85 years old) with a confirmed diagnosis of the studied condition (CADASIL or traumatic brain injury), without significant other neurological diseases or conditions that may interfere with the study results.

Ongoing Clinical Trials on Cerebrolysin Concentrate

  • Study of Cerebrolysin to improve arm function in patients recovering from ischemic stroke

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Romania

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    Romania

  • Study on Cerebrolysin and Sodium Chloride for Patients with CADASIL

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

Glossary

  • CADASIL: Cerebral Autosomal Dominant Arteriopathy with subcortical Infarcts and Leukoencephalopathy, a rare genetic disorder affecting blood vessels in the brain.
  • Traumatic Brain Injury (TBI): An injury to the brain caused by external force, often resulting in temporary or permanent impairment of cognitive, physical, and psychosocial functions.
  • Glasgow Outcome Scale Extended (GOSE): A scale used to assess functional outcomes in patients with brain injuries, measuring their level of recovery and independence in daily activities.
  • Intravenous Infusion: A method of administering medication directly into a vein using a needle or catheter.
  • Placebo: An inactive substance that looks like the drug being tested, used as a control in clinical trials to determine the effectiveness of the actual drug.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual drug or the placebo.
  • Cross-over Trial: A type of clinical trial where participants receive both the study drug and the placebo at different times during the study, allowing for comparison of effects within the same individual.
  • Neuroprotective: Describing a substance or treatment that protects nerve cells from damage or degeneration.
  • Neurotrophic: Promoting the growth, survival, and differentiation of neurons.
  • Nootropic: A substance that may improve cognitive function, particularly executive functions, memory, creativity, or motivation.

References

  1. http://clinicaltrials.eu/trial/study-on-cerebrolysin-and-sodium-chloride-for-patients-with-cadasil/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-cerebrolysin-and-sodium-chloride-for-recovery-in-patients-with-moderate-to-severe-traumatic-brain-injury/