Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

AmaNtadine for NeuroenhancEment in acutE patients Study - A prospective pilot proof of concept phase IIb study in intensive and intermediate care unit patients (ANNES)

This study, called ANNES, is investigating if a medicine called Amantadine can help patients who are in an 'unresponsive wakefulness syndrome' after a severe brain injury. This condition means someone is awake but doesn't respond to their surroundings. The researchers want to see if Amantadine can help these patients become more alert and responsive. They will give patients the medicine for 5 days and carefully watch for improvements in their consciousness, using a common medical scale. This is a pilot study, meaning it's an early step to find out if this treatment might work, before doing larger studies. It aims to see if Amantadine can enhance brain function in these very unwell patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsklinikum Tuebingen AöR

Enrolment target

Start

06 Mar 2024

unresponsive wakefulness syndrome not otherwise explained

What is this study about?

This research study, known as ANNES, is exploring a new way to help patients who are suffering from a severe brain injury. Sometimes, after a severe injury to the brain, a person might reach a state called 'unresponsive wakefulness syndrome'. This means they are awake, but they don't seem to respond or interact with people or their environment. It's a very challenging situation for patients and their families.

The study is focused on a medicine called Amantadine. Doctors already use Amantadine for other conditions, and some early ideas suggest it might help brain function in certain situations. The researchers want to carefully test if Amantadine can help improve the level of consciousness in patients with unresponsive wakefulness syndrome. They will give this medicine to patients and closely observe if they become more alert and responsive over a short period. This is a "pilot" study, which means it's an early-stage investigation to see if Amantadine shows enough promise to justify bigger research studies in the future.

The main goal is to see if patients show a noticeable improvement in their responsiveness after taking Amantadine for 5 days. For example, they'll check if patients become more awake or can follow simple commands. They will also look at longer-term effects after 90 days, like how well patients can think, their overall recovery, and whether there are changes in their brain activity. The hope is that this study could pave the way for new treatments to help people recover from severe brain injuries.

Key takeaways

This study explores if Amantadine can help patients with severe brain injury wake up and improve.
It focuses on 'unresponsive wakefulness syndrome', where patients are awake but don't respond.
Patients will receive Amantadine through a drip for 5 days, with careful monitoring.
This is an early-stage study to see if the treatment shows promise.
Regular assessments will track consciousness and recovery for up to 90 days.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, 18 years old or older. The study is open to both men and women.

The main requirement is that the patient has a severe brain injury that has led to an 'unresponsive wakefulness syndrome'. This means they are awake but not responding to their surroundings in the way someone typically would. This condition should not be caused by other known medical issues.

Because this is an early-stage study for very specific patients, there might be other medical conditions or circumstances that would mean someone couldn't take part. These details would be carefully checked by the medical team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is the patient 18 years old or older?
Does the patient have 'unresponsive wakefulness syndrome' after a severe brain injury?
Is the patient's condition not explained by other illnesses?
Has the medical team confirmed there are no other reasons not to join the study?

Answer every question to see your result.

What does participation involve?

If a patient takes part in this study, they will receive the study medicine, Amantadine, through a drip for 5 days. Throughout this time, and at specific points afterwards, the medical team will carry out several assessments. These assessments are designed to measure how alert and responsive the patient is, using special scales that doctors commonly use to check brain function. They will also look at things like how their movements are, their brain activity using special tests, and their general health.

There will be regular checks during the 5 days of treatment and then follow-up assessments for up to 90 days after starting the treatment. The research team will explain the exact schedule of visits and tests if a patient is considered for the study. The total duration a patient is actively monitored as part of the study would be around 3 months, though the medicine is only given for 5 days.

Potential risks and benefits

Patients taking part in this study might experience potential benefits, such as an improvement in their level of consciousness and overall brain function due to the Amantadine. However, as with any medicine, there are potential risks and side effects. The medical team will carefully monitor patients for any unwanted reactions, which will be fully explained before joining. Because this is an early-stage study, the full benefits and risks are not yet completely known. It's always important to remember that participating in any clinical trial is entirely voluntary, and a patient or their family can decide to withdraw from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What is 'unresponsive wakefulness syndrome'?

It's a serious condition after a severe brain injury where a person is awake but doesn't seem to respond or interact with their surroundings. They might open their eyes but won't follow commands or show signs of awareness.

What is Amantadine?

Amantadine is a medicine that doctors use for different conditions. In this study, it's being tested to see if it can help improve brain function and awakeness in people with severe brain injuries.

How will we know if the treatment is working?

Doctors will use special medical scales to measure the patient's level of consciousness and responsiveness. They will look for improvements, like becoming more alert or being able to react to things, especially after 5 days of treatment.

Is this a new medicine not used before?

No, Amantadine has been used for other conditions. This study is testing if it can be helpful for 'unresponsive wakefulness syndrome', which is a new use for it.

What if we change our mind about participating?

Taking part is always voluntary. You or your family can decide to stop participating in the study at any time, and it will not affect the medical care the patient receives.