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

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What is this study about?

This clinical trial is focused on studying a condition known as Subarachnoid Hemorrhage (SAH), which is a type of bleeding that occurs in the space surrounding the brain. The study is investigating a new treatment called EDV2209, which is a solution for injection designed to inhibit certain proteins in the body. The purpose of the study is to determine the safety and tolerability of this treatment in patients who have experienced a non-traumatic SAH.

Participants in the study will receive either the treatment EDV2209 or a placebo. The study is designed to be randomised and double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The treatment will be administered through a method called intracerebroventricular use, which involves delivering the medication directly into the brain’s ventricles, the fluid-filled spaces within the brain.

The study will follow participants over a period to monitor their health and any side effects they may experience. Researchers will assess various health indicators, such as vital signs and laboratory results, to ensure the treatment is safe. Additionally, the study will evaluate the clinical outcomes of the participants using scales like the National Institute of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (mRS) to measure recovery and progress. The study aims to provide valuable information about the potential benefits and risks of EDV2209 for patients with SAH.

1 joining the study

Eligibility is determined based on specific criteria, including age between 18 and 80 years, a diagnosis of moderate or severe subarachnoid hemorrhage (SAH) confirmed by a CT scan, and symptoms that began less than 8 hours ago.

Intracerebroventricular access must be obtained within 8 hours from the start of symptoms.

A World Federation of Neurological Surgeons (WFNS) score between 1 and 5 is required, assessed after SAH diagnosis but before the first dose of the investigational medication.

Informed consent is obtained from a trial guardian before any trial-related procedures begin.

2 administration of investigational medication

The investigational medication, EDV2209, is administered through intracerebroventricular use. This means it is injected directly into the brain’s ventricular system.

The medication is given in a solution form for injection.

3 monitoring and assessments

The primary focus is on the safety and tolerability of EDV2209. This involves monitoring for any adverse effects, changes in vital signs, and laboratory results.

Secondary assessments include clinical outcomes measured by various scales such as the National Institute of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (mRS).

The number of days spent in different care units and hospitals is recorded.

4 pharmacokinetic analysis

Pharmacokinetic studies are conducted to understand how EDV2209 is processed in the body. This includes measuring the concentration of the medication in the blood and cerebrospinal fluid (CSF) at different times.

Key measurements include the maximum concentration (Cmax), the time it takes to reach this concentration (Tmax), and the area under the concentration-time curve (AUC).

5 follow-up and conclusion

Follow-up assessments are conducted at discharge from neurosurgical care, and on Days 28 and 84 after the SAH event.

The trial is estimated to conclude by December 14, 2024.

Who Can Join the Study?

Male or female patients aged 18-80 years can participate.
Patients must have a moderate or severe subarachnoid hemorrhage (SAH), which is a type of bleeding in the space around the brain. This must be diagnosed with a CT scan, a special type of X-ray that gives detailed images of the brain.
The SAH should be caused, or suspected to be caused, by a ruptured saccular aneurysm, which is a bulging blood vessel in the brain that has burst. Symptoms must have started less than 8 hours ago.
Intracerebroventricular access must be obtained within 8 hours from the start of symptoms. This means a way to deliver treatment directly into the brain’s fluid spaces must be established.
A WFNS score between 1 and 5 is required. This score is used to assess the severity of the SAH and is determined after the diagnosis but before the first dose of the investigational medication.
Informed consent must be obtained from a trial guardian before starting any trial-related procedures. This means someone legally authorized to make decisions for the patient agrees to their participation.

Who Cannot Join the Study?

Patients who have a subarachnoid hemorrhage (SAH) caused by an injury cannot participate. A subarachnoid hemorrhage is bleeding in the space around the brain.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	14.03.2022

Trial locations

EDV2209 is a medication being studied for its safety and tolerability in patients who have experienced a subarachnoid hemorrhage, which is a type of bleeding in the brain. This medication is a MEK1/2 inhibitor, which means it works by blocking specific proteins that may be involved in the body’s response to this type of brain injury. The goal of using EDV2209 in this trial is to see if it can be safely administered to patients and to understand how well patients tolerate it.

Investigated diseases:

Subarachnoid haemorrhage

Subarachnoid Hemorrhage – This condition involves bleeding into the space surrounding the brain, often resulting from a ruptured aneurysm. It can lead to a sudden, severe headache, often described as the worst headache ever experienced. Other symptoms may include neck stiffness, nausea, vomiting, and sensitivity to light. As the condition progresses, it can cause confusion, seizures, or loss of consciousness. The bleeding increases pressure on the brain, which can lead to further complications. Immediate medical attention is crucial to manage the effects of the hemorrhage.

Trial ID:

2024-514590-22-00

Protocol code:

EDV2209_01

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

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