Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial.
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| Title: | Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial. |
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| Authors: | Poon, W. (AUTHOR), Matula, C. (AUTHOR), Vos, P. E. (AUTHOR), Muresanu, D. F. (AUTHOR), von Steinbüchel, N. (AUTHOR), von Wild, K. (AUTHOR), Hömberg, V. (AUTHOR), Wang, E. (AUTHOR), Lee, T. M. C. (AUTHOR), Strilciuc, S. (AUTHOR), Vester, J. C. (AUTHOR) |
| Source: | Neurological Sciences. Feb2020, Vol. 41 Issue 2, p281-293. 13p. 1 Diagram, 6 Charts. |
| Subjects: | Brain injuries, Saline solutions, Active recovery, Statistical significance |
| 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 141578019 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Poon%2C+W%2E%22">Poon, W.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Matula%2C+C%2E%22">Matula, C.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vos%2C+P%2E+E%2E%22">Vos, P. E.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Muresanu%2C+D%2E+F%2E%22">Muresanu, D. F.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22von+Steinbüchel%2C+N%2E%22">von Steinbüchel, N.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22von+Wild%2C+K%2E%22">von Wild, K.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hömberg%2C+V%2E%22">Hömberg, V.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wang%2C+E%2E%22">Wang, E.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lee%2C+T%2E+M%2E+C%2E%22">Lee, T. M. C.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Strilciuc%2C+S%2E%22">Strilciuc, S.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vester%2C+J%2E+C%2E%22">Vester, J. C.</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Neurological+Sciences%22">Neurological Sciences</searchLink>. Feb2020, Vol. 41 Issue 2, p281-293. 13p. 1 Diagram, 6 Charts. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Brain+injuries%22">Brain injuries</searchLink><br /><searchLink fieldCode="DE" term="%22Saline+solutions%22">Saline solutions</searchLink><br /><searchLink fieldCode="DE" term="%22Active+recovery%22">Active recovery</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+significance%22">Statistical significance</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s10072-019-04053-5 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 13 StartPage: 281 Subjects: – SubjectFull: Brain injuries Type: general – SubjectFull: Saline solutions Type: general – SubjectFull: Active recovery Type: general – SubjectFull: Statistical significance Type: general Titles: – TitleFull: Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Poon, W. – PersonEntity: Name: NameFull: Matula, C. – PersonEntity: Name: NameFull: Vos, P. E. – PersonEntity: Name: NameFull: Muresanu, D. F. – PersonEntity: Name: NameFull: von Steinbüchel, N. – PersonEntity: Name: NameFull: von Wild, K. – PersonEntity: Name: NameFull: Hömberg, V. – PersonEntity: Name: NameFull: Wang, E. – PersonEntity: Name: NameFull: Lee, T. M. C. – PersonEntity: Name: NameFull: Strilciuc, S. – PersonEntity: Name: NameFull: Vester, J. C. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 02 Text: Feb2020 Type: published Y: 2020 Identifiers: – Type: issn-print Value: 15901874 Numbering: – Type: volume Value: 41 – Type: issue Value: 2 Titles: – TitleFull: Neurological Sciences Type: main |
| ResultId | 1 |
