Patients on Intermediate Care and Intensive Care Unit (IMC and ICU) with unresponsive wakefulness syndrome not otherwise explained
Conditions
Interventions
Trade Name: Amantadin-ratiopharm®
Product Name: Amantadin-ratiopharm®
Pharmaceutical Form: Infusion
INN or Proposed INN: AMANTADINE HEMISULFATE
Other descriptive name: AMANTADINE HEMISULFATE
Concentra
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
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: o The patient understands the study procedures and voluntarily signs an informed consent document ? or o If 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 =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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) 60ms or interval of >480ms have to be excluded from treatment), simultaneous treatment with other QT time elongating drugs, hypo-magnesaemia or -kalemia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate that Amantadine is efficacious in increasing the level of vigilance/responsiveness as measured by clinical scores, mainly the Glasgow Coma Scale (GCS). ;Secondary Objective: •Improvement of vigilance measured via alternative scales (Richmond Agitation-Sedation Scale (RASS), Full Outline of UnResponsiveness (FOUR) Score Coma Scale), Intensive Care Delirium Screening Checklist (ICDSC), National Institute of health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Glasgow Outcome Scale – Extended (GOS-E), Coma Recovery Scale revised (CRS-R) and Montreal Cognitive Assessment (MoCA) after 90 days, EEG results, survival and clinical improvement reported within the therapists’ questionnaire. ;Primary end point(s): The primary outcome is the measure of the level of vigilance by GCS after 120 hrs (± 4hrs. ) from first dosis;Timepoint(s) of evaluation of this end point: 120 hrs (± 4hrs.) from first dosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Improvement of vigilance measured via alternative scales (Richmond Agitation-Sedation Scale (RASS), Full Outline of UnResponsiveness (FOUR) Score Coma Scale), Intensive Care Delirium Screening Checklist (ICDSC), National Institute of health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Glasgow Outcome Scale – Extended (GOS-E), Coma Recovery Scale revised (CRS-R) and Montreal Cognitive Assessment (MoCA) after 90 days;Timepoint(s) of evaluation of this end point: 90 days from first treatment | — |
Countries
Germany
Contacts
Public ContactZentrum für klinische Studien
University Hospital Tuebingen
Outcome results
None listed