A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)
This research study, called PRENUMBRA, is designed to test a new medicine called afamelanotide. It's for adults who have recently had a specific type of stroke called an ischaemic stroke, where a blood clot blocks blood flow to the brain. This study is specifically for people who are unable to receive the usual emergency treatments for this type of stroke, such as clot-busting injections (intravenous thrombolysis) or clot removal surgery (endovascular thrombectomy). The main purpose of this study is to carefully monitor and record any side effects or safety issues that might arise from taking afamelanotide. Researchers will also look at how patients recover after the stroke, including their daily activities and memory, to learn more about the medicine's potential effects.
At a glance
What is this study about?
This study is investigating a new medication called PRENUMBRA, which contains an active ingredient called afamelanotide. It's being tested in adults who have experienced a very serious medical event called an acute ischaemic stroke. This kind of stroke happens when a blood clot blocks an artery that supplies blood to the brain, causing damage.
Usually, when someone has this type of stroke, doctors try to remove the clot quickly using methods like 'clot-busting' medications given through a drip, or by 'clot removal' surgery. However, not everyone can have these treatments, sometimes because too much time has passed or due to other medical reasons. This study is specifically looking at patients who fall into this group – those who can't receive the standard emergency treatments.
The main focus of this study is to see how safe PRENUMBRA is. The researchers will be closely watching participants for any side effects or unexpected reactions to the medication. They will also collect information on how patients are recovering from their stroke, checking things like their movement, memory, and ability to do everyday tasks. This information will help doctors understand more about this new treatment and whether it could be a helpful option in the future.
Key takeaways
- This study is testing a new medication called PRENUMBRA for specific types of stroke.
- It's for adults who can't have other standard stroke treatments.
- The primary goal is to check how safe PRENUMBRA is and to look for side effects.
- Researchers will also track recovery of daily activities and memory.
- Your participation could help doctors find new treatments for future patients.
Who may be eligible?
This study is open to adults of any age, starting from 18 years old. Both men and women can take part.
The most important requirement is that you must have recently had a specific type of stroke called an acute ischaemic stroke. This is where a blood clot blocks blood flow to part of your brain. Crucially, you must also be unable to receive the standard emergency treatments for this kind of stroke, such as clot-busting medicine given through a vein or surgery to remove the clot.
There will be other medical checks by the study doctors to make sure it's safe and appropriate for you to join. They will review your medical history and current health to determine if you meet all the necessary criteria.
- Are you 18 years old or older?
- Have you recently had a stroke caused by a blood clot?
- Were you unable to receive standard emergency clot-busting injections or clot removal surgery?
- Are you willing to attend regular check-ups and assessments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given the study medication called PRENUMBRA. The study team will regularly check in with you to monitor your health and recovery. This will involve several visits to the clinic, where doctors and nurses will perform various assessments.
These assessments will include physical examinations, questions about your daily activities and memory, and possibly scans to see how your brain is recovering. The doctors will also carefully record any changes in your health, especially any side effects you might experience. The total duration of your participation in the study, including all follow-up appointments, will be clearly explained to you by the study team.
Potential risks and benefits
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Common questions
What kind of stroke is this study for?
It's for a stroke caused by a blood clot blocking an artery to the brain (called an acute ischaemic stroke).
Why can't I have the usual stroke treatments?
This study is for people who, for various medical reasons, cannot have the standard emergency treatments like clot-busting injections or clot removal surgery.
What is PRENUMBRA?
PRENUMBRA is the name of the new medication being tested in this study.
What is the main goal of the study?
The main goal is to find out if PRENUMBRA is safe and to track any side effects it might cause.
Will I get better if I join this study?
This study's main aim is to check safety. We don't know yet if it will make people better, but your participation helps doctors learn for the future.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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