Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT06052787

Recruitment Status : Recruiting

First Posted : September 25, 2023

Last Update Posted : September 28, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

ragab elshabasy, Ain Shams University

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	March 2025
Estimated Study Completion Date :	September 2025

Publications:

El Sayed I, Zaki A, Fayed AM, Shehata GM, Abdelmonem S. A meta-analysis of the effect of different neuroprotective drugs in management of patients with traumatic brain injury. Neurosurg Rev. 2018 Apr;41(2):427-438. doi: 10.1007/s10143-016-0775-y. Epub 2016 Aug 18.

Chamoun RB, Robertson CS, Gopinath SP. Outcome in patients with blunt head trauma and a Glasgow Coma Scale score of 3 at presentation. J Neurosurg. 2009 Oct;111(4):683-7. doi: 10.3171/2009.2.JNS08817.

Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM, Rosenfeld JV, Park KB. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018 Apr 27;130(4):1080-1097. doi: 10.3171/2017.10.JNS17352.

Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.

Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.

Gosseries O, Di H, Laureys S, Boly M. Measuring consciousness in severely damaged brains. Annu Rev Neurosci. 2014;37:457-78. doi: 10.1146/annurev-neuro-062012-170339. Epub 2014 Jun 23.

Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. doi: 10.1016/s0140-6736(75)92830-5.

Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654.

Muresanu DF, Florian S, Homberg V, Matula C, von Steinbuchel N, Vos PE, von Wild K, Birle C, Muresanu I, Slavoaca D, Rosu OV, Strilciuc S, Vester J. Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial. Neurol Sci. 2020 May;41(5):1171-1181. doi: 10.1007/s10072-019-04181-y. Epub 2020 Jan 2.

Obenaus A. (2022).Traumatic brain injury, Reference Module in Neuroscience and Biobehavioral Psychology, Elsevier.

Poon W, Matula C, Vos PE, Muresanu DF, von Steinbuchel N, von Wild K, Homberg V, Wang E, Lee TMC, Strilciuc S, Vester JC. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. 2020 Feb;41(2):281-293. doi: 10.1007/s10072-019-04053-5. Epub 2019 Sep 7. Erratum In: Neurol Sci. 2020 Jan 6;:

Rappaport M, Hall KM, Hopkins K, Belleza T, Cope DN. Disability rating scale for severe head trauma: coma to community. Arch Phys Med Rehabil. 1982 Mar;63(3):118-23.

Spritzer SD, Kinney CL, Condie J, Wellik KE, Hoffman-Snyder CR, Wingerchuk DM, Demaerschalk BM. Amantadine for patients with severe traumatic brain injury: a critically appraised topic. Neurologist. 2015 Jan;19(2):61-4. doi: 10.1097/NRL.0000000000000001.

Stan A, Birle C, Blesneag A, Iancu M. Cerebrolysin and early neurorehabilitation in patients with acute ischemic stroke: a prospective, randomized, placebo-controlled clinical study. J Med Life. 2017 Oct-Dec;10(4):216-222.

Talsky A, Laura R. Pacione, Tammy Shaw, Lori Wasserman, Adam Lenny, Amol Verma, Gillian Hurwitz, Robyn Waxman, Andrew Morgan, Shree Bhalerao .(2011).Pharmacological interventions for traumatic brain injury. BC Med J; 53:26-31

Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.

Friedland D, Hutchinson P. Classification of traumatic brain injury. Advances in Clinical Neuroscience and Rehabilitation. 27 Jul 2013.

To Top