Randomised, Double-blind, Placebo-controlled Study Investigating Safety and efficAcy of MLC901 in Post-traUmatic bRAin Injury: The SAMURAI Study Protocol

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aut.relation.endpagee059167
aut.relation.issue4en_NZ
aut.relation.journalBMJ Openen_NZ
aut.relation.startpagee059167
aut.relation.volume12en_NZ
aut.researcherFeigin, Valery
dc.contributor.authorPilipenko, Pen_NZ
dc.contributor.authorIvanova, AAen_NZ
dc.contributor.authorKotsiubinskaya, YVen_NZ
dc.contributor.authorFeigin, Ven_NZ
dc.contributor.authorMajdan, Men_NZ
dc.contributor.authorGrigoryeva, VNen_NZ
dc.contributor.authorKhrulev, AYen_NZ
dc.date.accessioned2022-04-28T04:01:54Z
dc.date.available2022-04-28T04:01:54Z
dc.date.copyright2022en_NZ
dc.date.issued2022en_NZ
dc.description.abstractINTRODUCTION: Traumatic brain injury (TBI) is a leading cause of death in young adults globally and 90% of cases are mild TBI. Treatment to facilitate recovery after TBI is needed. Traditional medicine MLC901 (NeuroAiD II) with neuroprotective and neuroproliferative properties in cellular and animal models of brain injury showed TBI-associated cognitive improvement in mild or moderate TBI. METHODS AND ANALYSIS: This is a randomised placebo-controlled trial, with 6-month treatment and 9-month follow-up, to determine the safety and efficacy of MLC901 in improving cognitive function in patients with cognitive impairment following mild TBI. This multicentre trial is conducted at the research centres of six hospitals/institutions in Russia. The primary outcome is to determine the effect of MLC901 on complex attention using the CNS Vital Signs (CNS-VS) online neurological test after 6-month treatment in patients receiving MLC901 compared with placebo. Secondary outcomes include other cognitive domains of CNS-VS and Rivermead Post Concussion Symptoms Questionnaire. The exploratory endpoints include Quality of Life after Brain Injury, Hospital Anxiety and Depression Scale and evaluation of improved neurological parameters 3 months after treatment completion. In addition, treatment compliance, concomitant therapies and adverse events will be collected. Investigators will use a secured online system for data entry. ETHICS AND DISSEMINATION: The study has been approved by the ethic committee of Ministry of Health of the Russian Federation (No: 58074). The results of this study will be published in a peer-review journal and presented at international conferences as poster presentations. TRIAL REGISTRATION NUMBER: NCT04861688.en_NZ
dc.identifier.citationBMJ Open 2022;12:e059167. doi: 10.1136/bmjopen-2021-059167
dc.identifier.doi10.1136/bmjopen-2021-059167en_NZ
dc.identifier.issn2044-6055en_NZ
dc.identifier.issn2044-6055en_NZ
dc.identifier.urihttps://hdl.handle.net/10292/15092
dc.languageengen_NZ
dc.publisherBMJ Publishing
dc.relation.urihttps://bmjopen.bmj.com/content/12/4/e059167
dc.rightsThis is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
dc.rights.accessrightsOpenAccessen_NZ
dc.subjectAnimalsen_NZ
dc.subjectBrain Concussionen_NZ
dc.subjectBrain Injuriesen_NZ
dc.subjectBrain Injuries, Traumaticen_NZ
dc.subjectDouble-Blind Methoden_NZ
dc.subjectDrugs, Chinese Herbalen_NZ
dc.subjectHumansen_NZ
dc.subjectMulticenter Studies as Topicen_NZ
dc.subjectQuality of Lifeen_NZ
dc.subjectRandomized Controlled Trials as Topicen_NZ
dc.subjectTreatment Outcomeen_NZ
dc.subjectdelirium & cognitive disordersen_NZ
dc.subjectneurological injuryen_NZ
dc.subjecttrauma managementen_NZ
dc.titleRandomised, Double-blind, Placebo-controlled Study Investigating Safety and efficAcy of MLC901 in Post-traUmatic bRAin Injury: The SAMURAI Study Protocolen_NZ
dc.typeJournal Article
pubs.elements-id453265
pubs.organisational-data/AUT
pubs.organisational-data/AUT/Faculty of Health & Environmental Science
pubs.organisational-data/AUT/Faculty of Health & Environmental Science/National Institute Stroke & Applied Neurosciences
pubs.organisational-data/AUT/Faculty of Health & Environmental Science/National Institute Stroke & Applied Neurosciences/NISAN - Stroke
pubs.organisational-data/AUT/Faculty of Health & Environmental Science/School of Clinical Sciences
pubs.organisational-data/AUT/PBRF
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences/HY Public Health & Psychosocial Studies 2018 PBRF
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