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Study to evaluate the effect of methylphenidate hydrochloride on the time to wake up in patients in a coma due to acute brain injury

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What is this trial about?

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

This study focuses on individuals experiencing a coma caused by an acute brain injury, which is a sudden and severe damage to the brain. The purpose of the study is to see if a specific medication can help patients wake up sooner. The treatment being tested is methylphenidate, which is given by mouth every day. Some participants will receive the active medication, while others will receive a placebo.

During the trial, participants are assigned to different groups to compare the effects of the medication against the placebo. The process involves monitoring how long it takes for a person to show signs of regained consciousness, which is the ability to be awake and aware of their surroundings. The study tracks how quickly patients respond to the treatment and observes their overall recovery and health status during their stay in the intensive care unit.

The research process

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

  1. Step 1

    Medication administration

    A daily dose of 20 mg of methylphenidate (a medication used to assist with alertness) is administered orally.

    The medication is provided as an oral treatment to help determine if it assists in the process of awakening from a coma (a state of prolonged unconsciousness) caused by an acute brain injury (sudden damage to the brain).

  2. Step 2

    Placebo administration

    As part of the study design, a placebo may be administered instead of the medication. a placebo is a substance that looks identical to the actual medication but contains no active substance.

  3. Step 3

    Monitoring for awakening

    The progress toward awakening is monitored by checking for a sustained improvement in consciousness.

    This improvement is confirmed through specific clinical assessments, such as the FOUR score or SECOND score, which are tools used by medical staff to measure levels of awareness. for a patient to be considered awake, these assessments must show consistent results during two exams performed one hour apart.

  4. Step 4

    Follow-up assessments

    Various clinical outcomes are tracked, including the proportion of patients who achieve clinical arousal (the ability to respond to stimuli).

    The length of time spent in the intensive care unit (icu) and survival rates are recorded.

    The status of the patient is evaluated at the 3-month mark using specific clinical scales to measure the level of recovery and functional independence.

Who can join the trial?

7 criteria

  • You must be an adult, which means you are 18 years old or older.
  • You must be staying in an intensive care unit, which is a special hospital area for patients who need very close and constant monitoring.
  • You must have an acute brain injury, which is a sudden and severe damage to the brain caused by an accident or other sudden event.
  • You must be unresponsive, meaning you are not reacting to people or surroundings. This is measured by specific medical scales like the FOUR score or SECONDs scale, which are tools doctors use to check how awake or alert a person is.
  • You must not be able to follow simple instructions or commands.
  • You must be hemodynamically stable, which means your blood pressure, heart rate, and blood flow are steady and within a safe range.
  • A legal proxy, which is a person authorized to make medical decisions for you, must provide informed consent, meaning they agree to your participation after understanding all the details.

Who cannot join the trial?

4 criteria

  • Having a severe mental handicap, which means a significant and permanent limitation in mental abilities or thinking skills that existed before the brain injury.
  • Having active seizures, which are sudden, uncontrolled electrical disturbances in the brain, or status epilepticus, which is a medical emergency where a seizure lasts too long or seizures happen one after another without the person waking up.
  • If it is expected that life-sustaining therapy (medical treatments used to keep a person alive, such as breathing machines) will be stopped, or if death is expected within 48 hours.
  • Having hepatic failure, which means the liver is not working properly, or renal failure, which means the kidneys are not working properly, as determined by the doctor.
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Investigated drugs

Methylphenidate is a medication used in this study to see if it can help patients who are in a coma due to a sudden brain injury wake up sooner.

What is already known about the treatment

  • Methylphenidate

    This medication is taken by mouth in tablet or capsule form and is widely used in medicine to treat attention-deficit hyperactivity disorder. It belongs to a group of drugs called central nervous system stimulants that work by increasing the levels of certain natural chemicals in the brain that help regulate focus and alertness. At a molecular level, it prevents the brain from reabsorbing these chemicals, allowing them to stay active in the spaces between nerve cells for longer periods. This study is investigating its ability to help patients wake up sooner after suffering a brain injury.

  • Placebo

    This is an inactive substance that looks and feels exactly like the actual medication but contains no active ingredients. It is used in clinical trials as a control to help researchers determine if the effects seen in patients are truly caused by the medicine being tested. Because it has no medicinal effect, it serves as a baseline for comparison to ensure the study results are accurate and reliable.

Investigated diseases

Coma due to acute brain injury - This condition occurs when a sudden injury to the brain causes a profound loss of consciousness. The injury can result from various events such as physical trauma, lack of oxygen, or internal bleeding. During this state, a person is unable to respond to their environment or interact with others. The progression involves a period of unconsciousness where basic bodily functions may continue, but awareness is absent. The state may eventually transition toward awakening or remain stable depending on the brain's recovery process.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524937-19-00Protocol codeMEAWAKE_1Estimated enrolment324 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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