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Erschienen in: Neurological Sciences 2/2020

07.09.2019 | Original Article

Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial

verfasst von: W. Poon, C. Matula, P. E. Vos, D. F. Muresanu, N. von Steinbüchel, K. von Wild, V. Hömberg, E. Wang, T. M. C. Lee, S. Strilciuc, J. C. Vester

Erschienen in: Neurological Sciences | Ausgabe 2/2020

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Abstract

Objective

To evaluate the safety and efficacy of Cerebrolysin as an add-on therapy to local standard treatment protocol in patients after moderate-to-severe traumatic brain injury.

Methods

The patients received the study medication in addition to standard care (50 mL of Cerebrolysin or physiological saline solution daily for 10 days, followed by two additional treatment cycles with 10 mL daily for 10 days) in a prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-centre phase IIIb/IV trial. The primary endpoint was a multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure.

Results

In 46 enrolled TBI patients (Cerebrolysin 22, placebo 24), three single outcomes showed stand-alone statistically significant superiority of Cerebrolysin [Stroop Word/Dots Interference (p = 0.0415, Mann–Whitney(MW) = 0.6816, 95% CI 0.51–0.86); Color Trails Tests 1 and 2 (p = 0.0223/0.0170, MW = 0.72/0.73, 95% CI 0.53–0.90/0.54–0.91), both effect sizes lying above the benchmark for “large” superiority (MW > 0.71)]. While for the primary multivariate ensemble, statistical significance was just missed in the intention-to-treat population (pWei-Lachin < 0.1, MWcombined = 0.63, 95% CI 0.48–0.77, derived standardized mean difference (SMD) 0.45, 95% CI −0.07 to 1.04, derived OR 2.1, 95% CI 0.89–5.95), the per-protocol analysis showed a statistical significant superiority of Cerebrolysin (pWei-Lachin = 0.0240, MWcombined = 0.69, 95% CI 0.53 to 0.85, derived SMD 0.69, 95% CI 0.09 to 1.47, derived OR 3.2, 95% CI 1.16 to 12.8), with effect sizes of six single outcomes lying above the benchmark for “large” superiority. Safety aspects were comparable to placebo.

Conclusion

Our trial suggests beneficial effects of Cerebrolysin on outcome after TBI. Results should be confirmed by a larger RCT with a comparable multidimensional approach.
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Metadaten
Titel
Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial
verfasst von
W. Poon
C. Matula
P. E. Vos
D. F. Muresanu
N. von Steinbüchel
K. von Wild
V. Hömberg
E. Wang
T. M. C. Lee
S. Strilciuc
J. C. Vester
Publikationsdatum
07.09.2019
Verlag
Springer International Publishing
Erschienen in
Neurological Sciences / Ausgabe 2/2020
Print ISSN: 1590-1874
Elektronische ISSN: 1590-3478
DOI
https://doi.org/10.1007/s10072-019-04053-5

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