Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

FINISHER – Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage

The FINISHER study is a major clinical trial for people who have experienced a very serious type of brain bleed called an aneurysmal subarachnoid hemorrhage (SAH). This condition can cause a lot of inflammation in the brain, which can lead to lasting problems. Researchers want to see if a particular treatment (Dexa 8 mg inject JENAPHARM) can reduce this inflammation and improve how well people recover. They are comparing it to a placebo (a dummy medicine) to understand if it truly makes a difference. The main goal is to find out if the study medicine can lower the rate of severe disability or death six months after the brain bleed, helping more people have a better outcome.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Enrolment target

334

Start

31 May 2024

Aneurysmal Subarachnoid Hemorrhage (SAH)

What is this study about?

The FINISHER study is looking for better ways to help people recover after a very serious type of brain bleed called an aneurysmal subarachnoid hemorrhage (SAH). This happens when a weakened blood vessel in the brain bursts. After such an event, the brain can become very inflamed, which can make things worse and lead to long-term problems or even death.

The researchers in this study believe that reducing this inflammation might help people recover more fully. They are testing a specific medicine, called Dexa 8 mg inject JENAPHARM, to see if it can achieve this. By comparing it to a 'placebo' (which looks like the medicine but has no active ingredients), they can figure out if the medicine itself is making a positive difference, rather than other factors.

The main thing they want to find out is if the study medicine can reduce the number of people who experience severe disability or death six months after their brain bleed. They'll be looking carefully at how people are doing and if they can live more independent lives. They also want to see if it helps with things like how long people stay in intensive care or hospital, and other complications that can happen after this type of brain bleed.

Key takeaways

FINISHER is a study for people who have had a brain bleed (SAH).
It tests if a specific medicine can help reduce severe disability or death.
The medicine aims to lower inflammation in the brain.
Participants will receive either the study medicine or a placebo.
Recovery will be tracked for up to one year, with a main check at six months.
You can withdraw from the study at any time.

Who may be eligible?

To take part in the FINISHER study, you would need to be at least 18 years old. There's no upper age limit, meaning older adults can also be included.

This study is for people who have recently experienced an aneurysmal subarachnoid hemorrhage (SAH). This is a very specific type of brain bleed that the doctors will diagnose.

The study welcomes both men and women to participate, ensuring that the results are relevant to everyone affected by this condition.

Quick self-check

Are you 18 years old or older?
Have you recently had an aneurysmal subarachnoid hemorrhage (brain bleed)?
Are you able to commit to follow-up appointments for up to a year?
Are you willing to potentially receive either the study medicine or a placebo?

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 the FINISHER study, you would be given either the study medicine (Dexa 8 mg inject JENAPHARM) or a placebo (a dummy medicine) through an injection. You wouldn't know which one you're receiving, as this helps ensure the results are fair.

The doctors and nurses will closely monitor your health throughout the study. This will likely involve regular check-ups, blood tests to measure inflammation, and scans of your brain (like CT scans or MRI scans) to see how you are recovering. They will also ask you to fill out questionnaires about your quality of life at various points after your brain bleed, including at discharge, and then after 90, 180, and 365 days. The main assessment of your recovery will happen six months after your brain bleed, where they will look at your overall ability to live independently. The study will likely involve hospital stays and follow-up visits over a year.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping doctors understand if the study medicine can improve recovery and reduce severe disability after a brain bleed. However, as with any medical treatment, there could be side effects or risks associated with the study medicine, even if they are uncommon. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is an aneurysmal subarachnoid hemorrhage (SAH)?

It's a serious type of brain bleed caused by a burst blood vessel in the brain.

What is the purpose of the FINISHER study?

To see if a new medicine can reduce severe disability or death after a brain bleed by calming down inflammation.

What is a placebo?

A 'dummy' medicine that looks like the real thing but contains no active ingredients. It helps researchers fairly test the new medicine.

How long will I be in the study?

Your recovery will be followed for up to one year after your brain bleed, with key checks at six months.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.