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Study on Amantadine Hemisulfate for Patients with Unresponsive Wakefulness Syndrome in Intensive and Intermediate Care Units

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What is this study about?

This clinical trial is focused on studying a condition known as unresponsive wakefulness syndrome, which is a state where a person is awake but not showing signs of awareness. The treatment being tested in this study is a medication called Amantadine, specifically in the form of Amantadin-ratiopharm® 200 mg Infusion Solution. This medication is administered through an infusion, which means it is delivered directly into the bloodstream over a period of time.

The purpose of the study is to see if Amantadine can help improve the alertness and responsiveness of patients who are in intensive or intermediate care units. The study will last for a total of five days, during which the patients will receive the medication. The main goal is to observe any changes in the patients’ level of alertness, which will be measured using a tool called the Glasgow Coma Scale (GCS). This scale helps doctors assess a person’s level of consciousness.

Throughout the study, the patients’ progress will be monitored using various scales and checklists, such as the Richmond Agitation-Sedation Scale (RASS) and the Coma Recovery Scale Revised (CRSR). These tools help provide a comprehensive view of the patients’ condition and any improvements in their responsiveness. The study aims to gather valuable information on the effectiveness of Amantadine in enhancing the recovery of patients with reduced consciousness.

1 joining the study

Participation begins after providing informed consent. If unable to consent due to reduced consciousness, a legal representative may provide consent.

Pregnancy is ruled out for women of childbearing potential through a blood test before starting the study medication.

2 eligibility confirmation

Eligibility is confirmed if reduced consciousness has lasted at least 72 hours, defined by a Glasgow Coma Scale (GCS) score of less than 8, with no other explanation.

An electroencephalogram (EEG) and electrocardiogram (ECG) must show no unusual findings.

3 treatment administration

The medication used is Amantadin-ratiopharm® 200 mg in the form of a solution for infusion.

The treatment is administered through an infusion over a period of 5 days.

4 primary outcome assessment

The main goal is to assess improvement in alertness and responsiveness using the Glasgow Coma Scale (GCS) after 5 days of treatment.

A patient is considered a responder if there is an improvement of at least 3 points on the GCS.

5 secondary outcome assessment

Secondary outcomes include improvement in alertness measured by various scales such as the Richmond Agitation-Sedation Scale (RASS) and the Full Outline of UnResponsiveness (FOUR) Score Coma Scale.

Other assessments include the Intensive Care Delirium Screening Checklist (ICDSC), National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Glasgow Outcome Scale – Extended (GOS-E), Coma Recovery Scale revised (CRSR), and Montreal Cognitive Assessment (MoCA).

Additional evaluations include EEG results, survival, and clinical improvement after 90 days.

Who Can Join the Study?

  • The patient or their legal representative must understand the study procedures and sign a document agreeing to participate.
  • If the patient is a woman who can have children, a test must show she is not pregnant before starting the study medication.
  • The patient must have reduced consciousness for at least 72 hours, which means they have a Glasgow Coma Scale (GCS) score of less than 8. The GCS is a way to measure how awake and responsive a person is.
  • The patient’s EEG (a test that checks brain activity) and ECG (a test that checks heart activity) must not show any unusual results.
  • Both male and female patients can participate.
  • The study includes patients who are considered a vulnerable population, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who have allergies or bad reactions to the study medication, Amantadine, cannot participate.
  • Individuals with severe kidney problems, as the medication may not be safe for them.
  • Patients with a history of seizures, which are sudden, uncontrolled electrical disturbances in the brain, are excluded.
  • People with severe liver disease, as the medication could affect their liver function.
  • Pregnant or breastfeeding women, to avoid any potential risk to the baby.
  • Individuals who are currently participating in another clinical trial, to prevent interference with study results.
  • Patients who have a history of drug or alcohol abuse, which could affect the study outcomes.
  • Anyone with a mental health condition that might interfere with their ability to follow study instructions.
  • Patients who have had a recent major surgery, as recovery could affect the study results.
  • Individuals with certain heart conditions, as the medication might not be safe for them.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Universitaetsklinikum Tuebingen AöR Tuebingen Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
20.03.2023

Trial locations

Investigated drugs:

Amantadine is being studied for its potential to improve alertness and responsiveness in patients who are in intensive and intermediate care units. The trial aims to see if this medication can effectively increase the level of consciousness, as measured by clinical scores like the Glasgow Coma Scale, after five days of treatment.

Unresponsive Wakefulness Syndrome – This condition, also known as a vegetative state, occurs when a person is awake but not aware of themselves or their environment. It often follows severe brain injury, where the patient may open their eyes, have sleep-wake cycles, and exhibit basic reflexes, but lacks conscious awareness. Over time, some individuals may show minimal signs of awareness, but many remain in this state for extended periods. The condition is characterized by the absence of voluntary actions or purposeful responses to stimuli. It is distinct from a coma, as patients in unresponsive wakefulness syndrome have periods of wakefulness. The progression of this condition varies, with some patients showing slight improvements, while others may remain unchanged.

Trial ID:
2024-512333-33-00
Protocol code:
2021-10
NCT ID:
NCT05479032
Trial Phase:
Therapeutic exploratory (Phase II)

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