AuthorisedTherapeutic exploratory (Phase II)Interventional

Methylphenidate for Early Awakening in Coma (MEAWAKE)

This research, called MEAWAKE, is investigating if a medication known as methylphenidate can help patients wake up earlier from a coma that has resulted from a serious brain injury. Participants will either receive methylphenidate or a placebo (a dummy pill that looks exactly like the real drug but contains no active ingredients). Researchers will carefully watch how long it takes for patients to show sustained signs of waking up. They will also look at other important factors like how many patients show signs of alertness, how long they stay in intensive care, and their overall health three months after the injury. This study includes adults aged 18 and over, both men and women.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rigshospitalet

Enrolment target

324

Start

27 Apr 2026

Coma due to acute brain injury

What is this study about?

When someone has a severe brain injury, they can sometimes go into a coma. This is a state where they are unconscious and unable to respond to their surroundings. The MEAWAKE study is a research project designed to explore whether a specific medication, called methylphenidate, can help people wake up more quickly from such a coma. Methylphenidate is a drug that affects chemicals in the brain and is sometimes used for other conditions, but its role in helping people wake from a coma after a brain injury is not yet fully understood.

In this study, some patients will receive methylphenidate, while others will receive a 'placebo'. A placebo is a dummy pill that looks identical to the real drug but contains no active medicine. This is a standard way to test new treatments, as it helps researchers understand if any improvements are genuinely due to the drug or simply to other medical care and the body's natural healing process. By comparing the two groups, the study aims to find out if methylphenidate makes a real difference in how quickly people regain consciousness.

The main thing the researchers will be watching for is how long it takes for a patient to show sustained signs of waking up. This means they'll be looking for consistent improvements in their awareness and ability to respond over a period of time. They will also be looking at other important aspects like how many patients achieve a state of alertness, how long they need to stay in the hospital's intensive care unit (ICU), and their recovery and overall health three months after their injury. The findings from this study could help doctors decide if methylphenidate could be a useful treatment to help people recover sooner from a coma after a brain injury.

Key takeaways

Tests methylphenidate to help patients wake from coma after brain injury.
Compares the drug to a 'dummy' pill (placebo).
Focuses on how quickly patients regain consciousness.
Includes adults aged 18 and over, both men and women.
Aims to improve recovery for patients with severe brain injuries.
Participation is voluntary and will not affect standard medical care.

Who may be eligible?

To be able to take part in this study, patients must be adults, meaning they need to be 18 years old or older. The study is open to both men and women.

The main condition for joining is that the patient is in a coma because of a sudden, severe brain injury. This means the coma must have happened recently as a direct result of damage to the brain.

There might be other specific health conditions or medications that would prevent someone from joining, even if they meet these general criteria. These details would be checked by the medical team involved in the study.

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.

Are you 18 years old or older?
Are you currently in a coma due to a recent brain injury?
Are you able to agree to participate (or does your legal representative)?
Are there any other serious health conditions that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If a patient participates in this study, they will be given either the study drug (methylphenidate) or a dummy pill (placebo). This will be decided randomly, much like flipping a coin, so neither the patient's family nor the doctors will know who is getting which. The medication will be given while the patient is still in the hospital.

The research team will closely monitor the patient's consciousness and recovery throughout their hospital stay. This will involve regular medical checks and assessments by doctors and nurses to see how the patient is responding and waking up. These assessments are usually part of the standard care for someone in a coma, but they will be more specifically recorded for the study.

After leaving the hospital, there will be a follow-up assessment typically around three months later. This might involve a hospital visit or a call to check on the patient's long-term recovery and overall health. The total duration of active participation through follow-up will depend on the individual patient's recovery, but the initial treatment phase will be during their time in intensive care.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For patients in this study, a potential benefit is that methylphenidate *might* help them wake up sooner from their coma, although this is what the study aims to find out. There is no guarantee of direct benefit for any individual joining the study, and some will receive a placebo which has no active drug. Potential risks could include side effects from methylphenidate, although the study design carefully considers patient safety. All patients will receive excellent medical care regardless of whether they receive the drug or the placebo. Furthermore, joining this study is completely voluntary, and a patient (or their legal representative, if they are unable to decide for themselves) has the right to withdraw from the study at any time without affecting their medical care.

Locations (4)

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

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Unverified
Austria
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Unverified
Denmark
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Unverified
Germany
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Unverified
France

Common questions

What is a coma?

A coma is a deep state of unconsciousness where a person can't be woken up, doesn't respond to their surroundings, and can't purposefully move.

What is methylphenidate?

Methylphenidate is a medication that affects brain chemicals. It's sometimes used for attention-related conditions, and this study aims to see if it helps with waking from a coma.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers know if the actual drug is making a difference.

Who will know if I'm getting the drug or the placebo?

Neither the patient's family nor the medical team will know who is getting the drug or the placebo during the study. This is called 'blinding' and helps keep the study fair.

Why is this study important?

This study aims to find new ways to help people wake up faster and recover better after a brain injury that caused a coma. It could lead to improved treatments in the future.