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A Study of TGD001 in Patients with Acute Ischemic Stroke to Test Safety and Effectiveness

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What is this trial about?

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

This study involves people who have had an acute ischemic stroke, which is a condition where blood flow to part of the brain is suddenly blocked, usually by a blood clot. When this happens, brain cells can be damaged or die because they do not get enough oxygen. The study will test a new medication called TGD001, which is designed to help dissolve blood clots. Some participants in the study will receive TGD001, while others will receive placebo. The medication will be given through a vein as a single dose.

The purpose of the study is to find out if TGD001 is safe and well-tolerated in people who have had an acute ischemic stroke. The study will also look at whether TGD001 might be helpful in treating this condition. The study is divided into two parts. In the first part, different doses of TGD001 will be tested to find the best dose to use. In the second part, participants will be randomly assigned to receive either TGD001 or placebo, and neither the participants nor the doctors will know which treatment is being given. The study will include people who either have a procedure called endovascular thrombectomy, which is a method to remove blood clots from blood vessels in the brain, or people who do not receive this procedure or the usual clot-dissolving treatment given through a vein.

During the study, doctors will closely monitor participants for any side effects or problems that might occur, particularly bleeding in the brain. They will also check how well participants are doing after their stroke. The study will help researchers understand whether TGD001 could be a useful treatment option for people who have had an acute ischemic stroke.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and treatment administration
Upon joining the study, your current condition will be assessed. Your stroke symptoms will be evaluated using a specific scale to measure their severity.
You will receive a single dose of the study medication called TGD001 through an intravenous infusion, which means the medication will be delivered directly into your vein.
Alternatively, you may receive a placebo, which is an inactive substance that looks like the study medication but contains only sodium chloride solution 0.9% (salt water). The type of treatment you receive will be determined randomly, and neither you nor your doctor will know which one you are receiving during certain phases of the study.
If you meet the requirements for a procedure called endovascular thrombectomy (a method to remove blood clots from brain vessels), this procedure may be performed as part of your treatment.
Step 2
Monitoring for bleeding complications
After receiving the study medication, you will be closely monitored for any signs of bleeding in the brain, which is referred to as symptomatic intracranial hemorrhage.
This monitoring is a key safety measure to ensure that the treatment does not cause harmful bleeding complications.
Step 3
Observation for side effects
Throughout your participation in the study, any new symptoms or health problems that develop after receiving the treatment will be recorded. These are called treatment emergent adverse events.
Your medical team will track all side effects to evaluate the safety and tolerability of the study medication.
Step 4
Follow-up assessments
You will undergo follow-up evaluations to assess your recovery and any changes in your condition.
These assessments will help determine how well the treatment worked and whether it was safe for you.

Who can join the trial?

6 criteria

You must be 18 years of age or older but younger than 80 years
You must have been able to perform daily activities independently before the stroke, meaning you had little to no disability that affected your daily life
You must have a diagnosis of acute ischemic stroke, which is a type of stroke caused by a blocked blood vessel in the brain, confirmed by brain imaging scans
Your brain imaging must show either a blocked blood vessel or an area of brain damage with a specific scoring system between 6 and 10, along with a target mismatch, which means there is brain tissue that can still be saved
Your stroke severity score must be 5 or higher when you arrive and must remain 5 or higher just before joining the study. This score measures how severe your stroke symptoms are
You must either meet the requirements for and receive a procedure called endovascular thrombectomy, which is a treatment to remove the blood clot from your brain using a thin tube inserted through your blood vessels, or you must not be receiving this procedure or the standard clot-dissolving medication given through a vein

Who cannot join the trial?

8 criteria

The study does not list specific exclusion criteria in the provided information. However, patients should discuss with their doctor whether they are suitable candidates for this trial based on their individual medical condition and circumstances.
Women who are pregnant (carrying a baby) or breastfeeding (nursing a baby) may not be eligible, as is common in many clinical trials to protect the unborn or nursing child.
Patients who have had a stroke (blocked blood flow to the brain) that is not caused by a blocked blood vessel, such as bleeding in the brain, cannot participate.
Patients who cannot undergo brain imaging tests like CT scan (a special x-ray of the brain) or MRI (a magnetic imaging test of the brain) may not be able to join the study.
Patients with severe allergies (bad reactions) to medications or previous bad reactions to similar treatments may be excluded.
Patients with other serious medical conditions that could make the study unsafe for them may not be able to participate.
Patients who are currently participating in another medical research study may not be eligible.
Patients who cannot give their informed consent (agreement to participate after understanding the study) or do not have a legal representative to provide consent may be excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Asklepios Kliniken Hamburg GmbH
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Hamburg, Germany
Gornoslaskie Centrum Mwdyczne
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Katowice, Poland
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
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Badalona, Spain

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Investigated drugs

TGD001
is an experimental medication being tested in this clinical trial. It is given as a single dose through an intravenous infusion, which means it is delivered directly into a vein. This medication is being studied to see if it is safe and well-tolerated in patients who have had an acute ischemic stroke, which is a type of stroke caused by a blocked blood vessel in the brain. The trial will test TGD001 in patients who receive a procedure to remove the blood clot from their brain, as well as in patients who do not receive this procedure or the standard clot-dissolving treatment.
Placebo
is an inactive substance that looks like the real medication but contains no active treatment. Some participants in this study will receive placebo instead of TGD001 so that researchers can compare the effects and better understand whether TGD001 is working.

What is already known about the treatment

TGD001 – TGD001 is an experimental medication given as a single dose through an intravenous infusion (directly into a vein) for patients who have suffered an acute ischemic stroke, which occurs when blood flow to the brain is blocked. This drug is currently being studied in early-phase clinical trials to determine its safety, tolerability, and potential effectiveness, and it has not yet been approved for standard medical use. It is being tested in stroke patients who either undergo a procedure to remove blood clots from brain vessels or who do not receive standard clot-dissolving treatments. While the specific details of how TGD001 works at the molecular level have not been fully disclosed in available trial information, it is being developed as a potential therapy to improve outcomes following stroke by addressing the damage caused by interrupted blood flow to brain tissue.

Investigated diseases

Acute Ischemic Stroke – Acute ischemic stroke is a condition that occurs when blood flow to a part of the brain is suddenly blocked, usually by a blood clot. This blockage prevents oxygen and nutrients from reaching brain tissue, causing brain cells in the affected area to begin dying within minutes. The condition develops rapidly and is considered a medical emergency. Common signs include sudden weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, dizziness, and severe headache. The extent of brain damage depends on how long the blood flow remains blocked and which area of the brain is affected. Without prompt intervention, the affected brain tissue continues to deteriorate, potentially leading to permanent disability.