AmaNtadine for NeuroenhancEment in acutE patients Study - A prospective pilot proof of concept phase IIb study in intensive and intermediate care unit patients (ANNES) - 2021-10

niversitaetsklinikum Tuebingen AöR0 个研究点目标入组 50 人开始时间: 2024年2月29日最近更新: 2024年7月22日

适应症

试验速览

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•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

•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

发起方

niversitaetsklinikum Tuebingen AöR