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AmaNtadine for NeuroenhancEment in acutE patients Study - A prospective pilot proof of concept phase IIb study in intensive and intermediate care unit patients (ANNES)
EU CTIS ID: 2024-512333-33-00
What this study is testing
To demonstrate that Amantadine is efficacious in increasing the level of vigilance/responsiveness as measured by clinical scores, mainly the Glasgow Coma Scale (GCS). The primary outcome is the measure of the level of vigilance by GCS after 120 hrs (± 4hrs.), i.e. 5 days, of treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- consent. Informed consent:o The patient understands the study proceduresand voluntarily signs an informed consentdocumentoro If a subject has per definition reducedconsciousness and therefore is not in a positionto provide written informed consent, prior to anystudy related assessments/procedures thepatient’s legal representative can give writteninformed consent. Females: pregnancy excluded by measurement ofhuman chorionic gonadotropin (hCG) in serum beforestart of study medication (in woman of child bearingpotential) Reduced consciousness, lasting at least 72 h, definedas GCS <8, not otherwise explained Inconspicuous EEG and ECG
You likely can't join if
- Women during pregnancy and lactation. History of hypersensitivity to the investigationalmedicinal product or to any drug with similar chemicalstructure or to any excipient present in thepharmaceutical form of the investigational medicinalproduct. Participation in other interventional study.(Participation in an observational trial is acceptable.) Reduced consciousness, otherwise sufficientlyexplained, such as reduced consciousness due tostatus epilepticus, hyperglycaemia, electrolyteimbalance, hyperkalaemia, akinetic crisis inParkinson’s disease) Delirium (Intensive CareDelirium Screening Checklist (ICDSC) > 4 or >5 inaphasic patients) History of epileptic seizures or status epilepticus Concomitant therapy with memantine Severe uncompensatedheart failure (NYHA IV) cardiomyopathy and myocarditis Atriventricular block (AV block) second-degree andthird-degree known bradykcardia (below 55 beats/minute) Known long QT interval (QTc according to Bazett > 420ms) or recognizable U-waves or congenital QTsyndrome in the Family history a history of serious ventricular arrhythmias, includingtorsade de pointes hypokalemia or hypomagnesemia concomitant therapy with Budipin or other QTprolongingdrugs impaired renal function, measured by glomerularfiltration rate (GFR) < 10 ml/min
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.