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Study on the Effects of Mepivacaine Hydrochloride for Patients with Neurological Symptoms After Ischemic Stroke

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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 medication called mepivacaine hydrochloride on patients who have experienced an ischemic stroke. An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow and potentially leading to neurological issues. The medication being tested, mepivacaine hydrochloride, is administered as a solution through a subcutaneous injection, which means it is injected under the skin.

The purpose of this study is to evaluate how effective and safe mepivacaine hydrochloride is in improving neurological symptoms that can occur after an ischemic stroke. These symptoms might include difficulties with movement, speech, or vision. Participants in the study will receive an injection of the medication, and researchers will observe any changes in their symptoms shortly after the injection.

Throughout the study, participants will be monitored to see if there is any improvement in their neurological symptoms, such as better language skills, motor skills, or visual abilities. The study aims to determine how many patients respond positively to the treatment with mepivacaine hydrochloride. This research could provide valuable insights into potential treatments for individuals who have suffered from an ischemic stroke.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. These include having experienced an ischemic stroke more than 30 days ago, being between 18 and 85 years old, and having at least one neurological deficit such as a motor deficit, aphasia, or visual scotoma.
Written consent is required, and participants must be affiliated with a social security scheme or equivalent.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current neurological symptoms. This includes scoring motor deficits using the Fugl-Meyer scale and assessing aphasia with the Aphasia Rapid Test.
Step 3
Administration of medication
The medication CARBOCAINE 20 mg/ml, which contains mepivacaine hydrochloride, is administered as a subcutaneous injection. This is a solution specifically prepared for injection.
Step 4
Post-injection evaluation
Approximately one hour after the injection, an evaluation is conducted to assess any improvement in symptoms. This involves comparing clinical scores for language, motor skills, and visual skills to those recorded before the injection.
Step 5
Ongoing monitoring
Participants are monitored for any changes in their condition and for any potential side effects of the medication. The study aims to determine the efficacy and safety of the treatment over time.

Who can join the trial?

7 criteria

Must have had an ischemic stroke more than 30 days ago. An ischemic stroke happens when a blood vessel in the brain is blocked, reducing blood flow.
Age must be between 18 and 85 years old.
Must have at least one of the following problems:
- Motor deficit: Difficulty in moving parts of the body, with a score of less than 56 on the Fugl-Meyer scale, which measures motor function.
- Aphasia: Trouble with speaking or understanding language, with a score of 4 or more on the Aphasia Rapid Test, which assesses language ability.
- Presence of a clinically observable visual scotoma: A spot in the vision that is missing or blurred.
- Must have given written consent to participate in the study.
- Must be affiliated with a social security scheme, Universal Medical Coverage (CMU), or any equivalent scheme.

Who cannot join the trial?

4 criteria

Patients who have not experienced an ischemic stroke. An ischemic stroke happens when a blood vessel supplying blood to the brain is blocked.
Patients who do not have neurological symptoms following an ischemic stroke. Neurological symptoms can include things like weakness, numbness, or difficulty speaking.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

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Hopital Beaujon
Clichy, France

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Investigated drugs

Mepivacaine is a medication being studied for its potential to help with neurological symptoms following a stroke. In this trial, it is given as an injection under the skin to see if it can improve the condition of patients who have had an ischemic stroke. The goal is to determine how effective and safe this treatment is for reducing the aftereffects of a stroke.

Mepivacaine Hydrochloride

What is already known about the treatment

Mepivacaine – Mepivacaine is administered subcutaneously and is currently being evaluated in clinical trials for its effectiveness and safety in treating neurological symptoms following an ischemic stroke. It is primarily used as a local anesthetic, and its mechanism of action involves blocking sodium channels on nerve cells, which prevents the initiation and transmission of nerve impulses, leading to a loss of sensation in the targeted area. Mepivacaine belongs to the pharmacological class of amide local anesthetics.

Investigated diseases

Ischemic stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes, leading to potential loss of function in the affected area. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, vision problems, dizziness, and loss of balance or coordination. The progression of symptoms can vary, with some individuals experiencing rapid onset and others having more gradual development. Immediate medical attention is crucial to minimize brain damage and improve outcomes.