AmaNtadine for NeuroenhancEment in acutE patients Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

•Subjects meeting all of the following criteria will be considered for admission to the trial:
•Must be = 18 years at the time of signing the informed consent.
•Informed consent:
oThe patient understands the study procedures and voluntarily signs an informed consent document
?or
oIf a subject has per definition reduced consciousness and therefore is not in a position to provide written informed consent, prior to any study related assessments/procedures the patient’s legal representative can give written informed consent. Inclusion of this patient is also possible if two independent physicians agree to include the patient in the study. In this case the Inform Consent of the Patient or his/her legal representative will be sought retroactively as soon as possible .
•Able to adhere to the study visit schedule and other protocol requirements.
•Females: pregnancy excluded by measurement of human chorionic gonadotropin (hCG) in serum before start of study medication
•Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 4 days (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasoing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
1 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success
2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
•All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
•All subjects must agree not to share medication.
•Reduced consciousness, defined as GCS <8, lasting at least 72 h, ,not otherwise explained
•Inconspicuous EEG and ECG

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Subjects presenting with any of the following criteria will not be included in the trial:
•Women during pregnancy and lactation.
•History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
•Participation in other interventional study. (Participation in an observational trial is acceptable.)
•Reduced consciousness, otherwise sufficiently explained, such as reduced consciousness due to status epilepticus, hyperglycaemia, electrolyte imbalance, hyperkalaemia, akinetic crisis in Parkinson’s disease) Reduced consciousness, otherwise sufficiently explained
•Delirium (Intensive Care Delirium Screening Checklist (ICDSC) > 4 or >5 in aphasic patients)
•History of epileptic seizures or status epilepticus
•Concomitant therapy with memantine
•Pre-existing cardial conditions Severe uncompensatede.g. heart failure (NYHA IV)
•cardiomyopathy and, myocarditis
•Atriventricular block (AV block) second-degree and third-degree
•known bradykcardia (below 55 beats/minute)
•Known long QT interval (QTc according to Bazett > 420 ms) or recognizable U-waves or congenital QT syndrome in the Family history
•a history of serious ventricular arrhythmias, including torsade de pointes
•hypokalemia or hypomagnesemia
•concomitant therapy with Budipin or other QT-prolonging drugs
•impaired renal function, measured by glomerular filtration rate (GFR) < 10 ml/min
•a history of serious ventricular arrhythmias, including torsade de pointes
•arrythmia (patients with a QTc time increase of >60ms or interval of >480ms have to be excluded from treatment), simultaneous treatment with other QT time elongating drugs, hypo-magnesaemia or -kalemia)

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

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