Table 2 Synopsis of planned study visits. The whole study duration for each subject will be 3 months incl. screening and follow-up procedures

Timeline (days)

1

2

3

4

5

6

-

90

Informed consent

X

Inclusion /exclusion criteria

X (using a screening sheet)

X (recheck)

Patient history, demographics

X

Documentation of clinical data

X

Documentation of drug history

X

Physical and Neurological examination

X

Blood tests (approx. 10 ml)

X

Start of trial drug

X

Responsiveness check

X*

Pregnancy Test (measurement of hCG in serum) in woman of child bearing potential

X

GCS

X*

X

X*

X

X

X*

X

X

FOUR Score Coma Scale

X

X

X

X

X

X

X

X

RASS

X

X

X

X

X

X

X

X

ICDSC

X

X

X

X

X

X

X

X

EEG

X

X

X

ECG

X

X

X

X

X

X

X

mRS

X

X

X

NIHSS

X

X

X

GOS-E

X

X

X

X

X

X

X

X

CRS-R

X

X

X

X

X

X

X

X

MoCA

X

X

Questionnaire for therapists

X

X

X

X

X

X

X

(X)

Documentation of (S)AE

X

X

X

X

X

X

X