Lost and found: what we have learned from the progesterone for traumatic brain injury trials

Written by Stein DG

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 [1], 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...

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