A short opinion piece updating “Lost in translation: understanding the failure of the progesterone/traumatic brain injury Phase III trials”
In a previous commentary published in Future Neurology , I discussed some of the reasons that the clinical trials for progesterone treatment for traumatic brain injury (TBI) failed. Despite hundreds of preclinical investigations demonstrating progesterone’s efficacy in the treatment of TBI and stroke, two Phase III clinical trials found no improvements in patients with moderate-to-severe TBI given progesterone compared with placebo controls [2,3]. The 100% failure rate for clinical trials of neuroprotective agents for brain injury still stands. The TBI trial reports published in the New England Journal of Medicine argued that, among other issues, preclinical laboratory animal studies were too dissociated from real-life clinical situations to translate to human testing.
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