NCT05551871 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Barlow KM
Traumatic brain injury. Handb Clin Neurol. 2013;112:891-904. doi: 10.1016/B978-0-444-52910-7.00011-8. Review.
Iaccarino C, Carretta A, Nicolosi F, Morselli C
Epidemiology of severe traumatic brain injury. J Neurosurg Sci. 2018 Oct;62(5):535-541. doi: 10.23736/S0390-5616.18.04532-0. Review.
Kumar A, Loane DJ
Neuroinflammation after traumatic brain injury: opportunities for therapeutic intervention. Brain Behav Immun. 2012 Nov;26(8):1191-201. doi: 10.1016/j.bbi.2012.06.008. Epub 2012 Jun 21. Review.
Menon DK, Schwab K, Wright DW, Maas AI; Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health
Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. doi: 10.1016/j.apmr.2010.05.017. Review.
Peng W, Yang J, Yang B, Wang L, Xiong XG, Liang Q
Impact of statins on cognitive deficits in adult male rodents after traumatic brain injury: a systematic review. Biomed Res Int. 2014;2014:261409. doi: 10.1155/2014/261409. Epub 2014 Jul 23. Review.
Wible EF, Laskowitz DT
Statins in traumatic brain injury. Neurotherapeutics. 2010 Jan;7(1):62-73. doi: 10.1016/j.nurt.2009.11.003. Review.

Effects of Usage of Simvastatin in Mild to Moderate Traumatic Brain Injury (TBI) Patients. Could it Make a Difference?

Clinical trial NCT05551871 - References