Muresanu et al. 2020 showed significant effect size of Cerebrolysin® in the multidimensional outcome ensemble. In all 13 single outcome scales Cerebrolysin® was superior to placebo and 6 outcome measurements demonstrated stand-alone statistical significance.
A reduction of the mortality rate was shown in the meta-analysis of Vester et al. 2021 , as 8.4% of patients died in the placebo group vs. only 3.9% in the Cerebrolysin® group.
As early as on day 10, CAPTAIN 2 (Muresanu et al. 2020 ) showed superiority of Cerebrolysin® versus placebo overall (MW = 0.54) and in 6 out of 7 single outcome scales. on day 30, the effect size increased to MW = 0.576. So already one early treatment cycle brings medium superiority on day 30.
The CAPTAIN meta-analysis (Vester et al. 2021) found normalization of the HADS score (Score 0-7 at Day 90) in 70.5% of patients treated with Cerebrolysin® as compared to 39.5% of patients in the placebo group. The rate difference of 31% is a substantial reduction of depression.
The most common neurocognitive consequences of TBI at all levels of severity are disturbances of memory, attention and executive functioning. The CAPTAIN 2 study (Muresanu et al., 2020) investigated exactly these important domains with the following assessment tools:
Muresanu, Dafin f., et al. „Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIn II trial.“ neurological Sciences 41.5 (2020): 1171-1181.
Vester, Johannes C., et al. „Cerebrolysin® after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIn trial series.“ neurological Sciences (2021): 1-11.
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