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Amantadine Hemisulfate

Researchers are conducting a clinical trial to investigate the effectiveness of Amantadine Hemisulfate in improving consciousness levels in patients with unresponsive wakefulness syndrome. This study, known as the ANNES trial, aims to determine if Amantadine can enhance vigilance and responsiveness in intensive and intermediate care unit patients.

Table of Contents

What is Amantadine Hemisulfate?

Amantadine Hemisulfate is a medication that is being studied for its potential to help patients with reduced consciousness[1]. It is currently available as a solution for infusion, which means it is given directly into the bloodstream through a vein. The brand name of this medication in the study is Amantadin-ratiopharm® 200 mg Infusionslösung[1].

Medical Condition: Unresponsive Wakefulness Syndrome

The medical condition being studied is called unresponsive wakefulness syndrome[1]. This is a state where a person appears to be awake but shows no signs of awareness of themselves or their environment. It’s important to note that this condition is not otherwise explained by other medical issues, which means doctors have ruled out other reasons for the patient’s state.

Study Objectives

The main goal of this study is to see if Amantadine can help increase the level of alertness and responsiveness in patients with unresponsive wakefulness syndrome[1]. Researchers will measure this using various clinical scores, with the primary focus on the Glasgow Coma Scale (GCS). This scale helps medical professionals assess a person’s level of consciousness.

Additionally, the study aims to look at other aspects of improvement, including:

  • Changes in other scales that measure awareness and brain function
  • Results from brain wave tests (EEG)
  • Survival rates
  • Overall clinical improvement as reported by therapists

Eligibility Criteria

To participate in this study, patients must meet certain criteria[1]:

Inclusion Criteria:

  • Consent must be given (either by the patient if able, or by a legal representative)
  • For women who could potentially become pregnant, a pregnancy test must be negative
  • Reduced consciousness (defined as a GCS score less than 8) for at least 72 hours, with no other clear explanation
  • Normal EEG (brain wave test) and ECG (heart rhythm test)

Exclusion Criteria:

Patients cannot participate if they have any of the following[1]:

  • Pregnancy or breastfeeding
  • Allergies to the study medication or similar drugs
  • Participation in other interventional studies
  • Reduced consciousness that can be explained by other conditions (like seizures, high blood sugar, or electrolyte imbalances)
  • History of epileptic seizures
  • Taking certain other medications (like memantine)
  • Severe heart problems
  • Certain heart rhythm abnormalities
  • Severely reduced kidney function

Treatment Details

The study medication, Amantadine Hemisulfate, is given as an infusion directly into the vein[1]. The maximum daily dose is 200 mg, and the total maximum dose over the course of treatment is 1000 mg. The treatment period lasts for 5 days.

Measuring Effectiveness

The main way researchers will determine if the treatment is working is by looking at the Glasgow Coma Scale (GCS) score after 5 days of treatment[1]. A patient is considered to have responded to the treatment if their GCS score improves by at least 3 points.

The study will also look at other measures of improvement, including[1]:

  • Richmond Agitation-Sedation Scale (RASS): This scale measures levels of sedation and agitation.
  • Full Outline of UnResponsiveness (FOUR) Score: Another scale to assess consciousness in critically ill patients.
  • Intensive Care Delirium Screening Checklist (ICDSC): This helps identify delirium in intensive care patients.
  • National Institute of Health Stroke Scale (NIHSS): This scale assesses the severity of stroke symptoms.
  • Modified Rankin Scale (mRS): This measures the degree of disability in daily activities.
  • Glasgow Outcome Scale – Extended (GOS-E): This assesses functional recovery after brain injury.
  • Coma Recovery Scale Revised (CRS-R): This is used to assess patients with disorders of consciousness.
  • Montreal Cognitive Assessment (MoCA): This is a brief test to screen for mild cognitive impairment.

These assessments will be done 90 days after the start of treatment to see if there are long-term improvements in the patients’ condition[1].

Aspect Details
Study Name ANNES (AmaNtadine for NeuroenhancEment in acutE patients Study)
Drug Studied Amantadine Hemisulfate
Condition Treated Unresponsive Wakefulness Syndrome
Primary Outcome Improvement in Glasgow Coma Scale after 5 days of treatment
Secondary Outcomes Improvements in various consciousness and cognitive function scales
Treatment Duration 5 days
Maximum Daily Dose 200 mg
Administration Route Infusion

FAQ

  • What is the main goal of the ANNES trial? The main goal is to show that Amantadine is effective in increasing the level of alertness and responsiveness in patients, primarily measured by the Glasgow Coma Scale (GCS) after 5 days of treatment.
  • Who can participate in this clinical trial? Participants must have reduced consciousness (GCS <8) lasting at least 72 hours, with no other clear explanation. They must also have normal EEG and ECG results, and for women, pregnancy must be excluded.
  • How is the effectiveness of Amantadine measured in this study? The primary measure is the improvement in the Glasgow Coma Scale (GCS) score after 5 days of treatment. A patient is considered responsive if they improve by at least 3 points on the GCS.
  • Are there any secondary objectives in this trial? Yes, the trial also aims to measure improvements using other scales such as the Richmond Agitation-Sedation Scale, Full Outline of UnResponsiveness Score, and various other assessments of cognitive function and recovery.
  • What are some reasons why a person might not be able to participate in this trial? Exclusion criteria include pregnancy, lactation, history of epileptic seizures, severe heart conditions, impaired kidney function, and taking certain medications that may interact with Amantadine.

Ongoing Clinical Trials on Amantadine Hemisulfate

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

    Not recruiting

    1 1 1
    Investigated drugs:
    Germany

Glossary

  • Unresponsive Wakefulness Syndrome: A condition where a person appears awake but shows no signs of awareness of themselves or their environment.
  • Glasgow Coma Scale (GCS): A scoring system used to assess the level of consciousness in a person following a brain injury.
  • Amantadine Hemisulfate: A medication being studied for its potential to improve consciousness levels in patients with reduced awareness.
  • Electroencephalogram (EEG): A test that records electrical activity in the brain.
  • Electrocardiogram (ECG): A test that records the electrical activity of the heart.
  • Delirium: A serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment.
  • Glomerular Filtration Rate (GFR): A test used to check how well the kidneys are working, specifically how much blood passes through the glomeruli each minute.
  • Torsade de Pointes: A specific type of abnormal heart rhythm that can be dangerous.
  • QT Interval: A measurement on an electrocardiogram that represents the time it takes for the heart to contract and recover.

References

  1. http://clinicaltrials.eu/trial/study-on-amantadine-hemisulfate-for-patients-with-unresponsive-wakefulness-syndrome-in-intensive-and-intermediate-care-units/