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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bispebjerg Hospital Copenhagen Denmark

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Ludwig Maximilian University Of Munich Munich Germany
Rigshospitalet Copenhagen Denmark
Jdyugaah Kkcbog Ueqvfvmfjv Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.06.2026
Denmark Denmark
Not yet recruiting
01.06.2026
France France
Not yet recruiting
01.06.2026
Germany Germany
Not yet recruiting
01.06.2026

Trial locations

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.

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 ID:
2025-524937-19-00
Protocol code:
MEAWAKE_1
Trial Phase:
Therapeutic exploratory (Phase II)

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