In short
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.
At a glance
- 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
What is Amantadine Hemisulfate?
Amantadine Hemisulfate is a medication that is being studied for its potential to help patients with reduced consciousness. 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.
Medical Condition: Unresponsive Wakefulness Syndrome
The medical condition being studied is called unresponsive wakefulness syndrome. 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. 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:
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:
- 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. 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. 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:
- 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.