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1,4-Diamino-2,3-Dicyano-1,4-Bis(O-Aminophenylmercapto)Butadiene Hemiethanolate

This article discusses a clinical trial investigating the use of EDV2209, a MEK1/2 inhibitor, in patients with subarachnoid hemorrhage (SAH). The study aims to evaluate the safety, tolerability, and potential clinical benefits of EDV2209 in treating this severe condition. The trial is designed as a randomized, double-blind, placebo-controlled study with multiple ascending doses, marking the first time this drug is being tested in humans for this specific condition.

Table of Contents

What is EDV2209?

EDV2209 is a new medication being studied for the treatment of subarachnoid hemorrhage (SAH), a type of bleeding in the brain. Its scientific name is 1,4-diamino-2,3-dicyano-1,4-bis(o-aminophenylmercapto)butadiene hemiethanolate. This medication is classified as a MEK1/2 inhibitor, which means it works by blocking specific proteins involved in cell growth and survival.[1]

What is Subarachnoid Hemorrhage (SAH)?

Subarachnoid hemorrhage (SAH) is a serious medical condition where bleeding occurs in the space between the brain and the thin tissues that cover it. This is often caused by a ruptured aneurysm, which is a weak spot in a blood vessel that bulges and then bursts. SAH is a life-threatening emergency that requires immediate medical attention.[1]

How EDV2209 Works

EDV2209 is designed to help patients with SAH by targeting specific cellular processes. As a MEK1/2 inhibitor, it may help reduce the damage caused by the bleeding and potentially improve outcomes for patients. However, the exact mechanisms are still being studied in clinical trials.[1]

Clinical Trial Details

A clinical trial is currently underway to evaluate EDV2209. Here are some key details about the study:

  • It is a randomized, double-blind, placebo-controlled trial. This means that participants are randomly assigned to receive either EDV2209 or a placebo, and neither the patients nor the researchers know who is receiving which treatment.
  • The trial is testing multiple ascending doses of EDV2209, which means they are gradually increasing the dose to determine the safest and most effective amount.
  • This is a first-in-human trial, meaning it’s the first time EDV2209 is being tested in people.
  • The main goal is to determine the safety and tolerability of EDV2209 in patients with SAH.[1]

Eligibility Criteria

To participate in the clinical trial, patients must meet certain criteria. Some of the key eligibility requirements include:

  • Age 18-80 years
  • Diagnosed with moderate or severe SAH caused by a ruptured aneurysm
  • Symptoms started less than 8 hours before treatment
  • A specific severity score (WFNS score) between 1-5

There are also several factors that would exclude a patient from participating, such as other causes of bleeding, expected survival less than 48 hours, or pregnancy.[1]

Potential Benefits

While the effectiveness of EDV2209 is still being studied, the researchers hope to see several potential benefits:

  • Improved clinical outcomes for SAH patients
  • Reduced length of stay in intensive care and hospital
  • Better overall recovery as measured by various neurological scales[1]

Safety and Side Effects

A primary focus of the clinical trial is to assess the safety of EDV2209. Researchers will be closely monitoring:

  • The frequency and severity of side effects
  • Changes in vital signs and laboratory results
  • Any serious adverse events that may occur

It’s important to note that as this is a new medication, not all potential side effects may be known at this time.[1]

How EDV2209 is Administered

EDV2209 is given as a solution for injection. In this clinical trial, it is administered intracerebroventricularly, which means it is injected directly into the fluid-filled spaces (ventricles) of the brain. This method of administration allows the medication to reach the affected areas more directly.[1]

It’s important to remember that EDV2209 is still an experimental treatment. If you or a loved one has experienced a subarachnoid hemorrhage, always consult with your healthcare provider about the most appropriate treatment options available.

Aspect Details
Study Type Interventional, randomized, double-blind, placebo-controlled, multiple-ascending-dose, first-in-human trial
Drug Name EDV2209 (1,4-Diamino-2,3-Dicyano-1,4-Bis(O-Aminophenylmercapto)Butadiene Hemiethanolate)
Condition Subarachnoid Hemorrhage (SAH)
Primary Objective Assess safety and tolerability of EDV2209 in SAH patients
Key Inclusion Criteria Age 18-80, moderate to severe SAH, symptoms <8 hours, WFNS score 1-5
Key Exclusion Criteria SAH due to trauma, expected survival <48 hours, severe concomitant conditions
Primary Endpoints Frequency of adverse events, changes in vital signs and lab results
Secondary Endpoints Clinical outcomes (NIHSS, mRS, GOS-E), length of hospital stay, pharmacokinetics
Follow-up Duration Up to 84 days after SAH

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to determine the safety and tolerability of EDV2209 in patients with subarachnoid hemorrhage (SAH) who receive at least one dose of the investigational medicinal product.
  • Who can participate in this clinical trial? Participants must be male or female patients aged 18-80 years with moderate or severe SAH diagnosed within 8 hours of symptom onset. They must have intracerebroventricular access obtained within 8 hours and a WFNS score of 1-5. Informed consent from a trial guardian is required.
  • What is EDV2209 and how is it administered? EDV2209 is a MEK1/2 inhibitor being studied for its potential effects on SAH. It is administered as a solution for injection through intracerebroventricular use, which means it's delivered directly into the brain's ventricles.
  • What are the secondary objectives of the trial? Secondary objectives include assessing clinical outcomes in patients treated with EDV2209, evaluating the length of stay in various hospital units, and studying the pharmacokinetic properties of the drug.
  • How long will patients be followed in this trial? Patients will be followed for at least 84 days after SAH. Various assessments will be conducted at discharge, Day 28, and Day 84 to evaluate the drug's effects and patient outcomes.

Ongoing Clinical Trials on 1,4-Diamino-2,3-Dicyano-1,4-Bis(O-Aminophenylmercapto)Butadiene Hemiethanolate

  • Study on the Safety of EDV2209 for Patients with Brain Bleeding (Subarachnoid Hemorrhage)

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Subarachnoid Hemorrhage (SAH): A type of stroke caused by bleeding in the space between the brain and the surrounding membrane. It's often due to a ruptured aneurysm and can be life-threatening.
  • MEK1/2 inhibitor: A type of drug that blocks specific enzymes (MEK1 and MEK2) involved in cell growth and survival. In this trial, EDV2209 is being studied as a MEK1/2 inhibitor for SAH treatment.
  • Intracerebroventricular: A method of drug administration where the medication is delivered directly into the fluid-filled spaces (ventricles) of the brain.
  • WFNS score: World Federation of Neurosurgical Societies scale, used to assess the severity of subarachnoid hemorrhage. It ranges from 1 (mild) to 5 (severe).
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active ingredient. In this trial, it's described as a salt solution.
  • NICU: Neurological Intensive Care Unit, a specialized hospital unit for patients with severe neurological conditions.
  • Modified Rankin Scale (mRS): A scale used to measure the degree of disability in patients who have suffered a stroke.
  • Glasgow Outcome Scale Extended (GOS-E): An assessment tool used to evaluate functional outcomes in patients with brain injuries.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-of-edv2209-for-patients-with-brain-bleeding-subarachnoid-hemorrhage/