AmaNtadine for NeuroenhancEment in acutE patients Study - A prospective pilot proof of concept phase IIb study in intensive and intermediate care unit patients (ANNES)
- Conditions
- unresponsive wakefulness syndrome nototherwise explainedTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-512333-33-00
- Lead Sponsor
- niversitaetsklinikum Tuebingen AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method