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Clinical Trial
. 2017 Jan 1;34(1):115-120.
doi: 10.1089/neu.2015.4313. Epub 2016 Apr 15.

Very Early Administration of Progesterone Does Not Improve Neuropsychological Outcomes in Subjects with Moderate to Severe Traumatic Brain Injury

Felicia C Goldstein  1 , Angela F Caveney  2 , Vicki S Hertzberg  3 , Robert Silbergleit  4 , Sharon D Yeatts  5 , Yuko Y Palesch  5 , Harvey S Levin  6 , David W Wright  7
Affiliations
Clinical Trial

Very Early Administration of Progesterone Does Not Improve Neuropsychological Outcomes in Subjects with Moderate to Severe Traumatic Brain Injury

Felicia C Goldstein et al. J Neurotrauma. .

Abstract

A Phase III, double-blind, placebo-controlled trial (ProTECT III) found that administration of progesterone did not reduce mortality or improve functional outcome as measured by the Glasgow Outcome Scale Extended (GOSE) in subjects with moderate to severe traumatic brain injury. We conducted a secondary analysis of neuropsychological outcomes to evaluate whether progesterone is associated with improved recovery of cognitive and motor functioning. ProTECT III was conducted at 49 level I trauma centers in the United States. Adults with moderate to severe TBI were randomized to receive intravenous progesterone or placebo within 4 h of injury for a total of 4 days. At 6 months, subjects underwent evaluation of memory, attention, executive functioning, language, and fine motor coordination/dexterity. Chi-square analysis revealed no significant difference in the proportion of subjects (263/280 progesterone, 283/295 placebo) with Galveston Orientation and Amnesia Test scores ≥75. Analyses of covariance did not reveal significant treatment effects for memory (Buschke immediate recall, p = 0.53; delayed recall, p = 0.94), attention (Trails A speed, p = 0.81 and errors, p = 0.22; Digit Span Forward length, p = 0.66), executive functioning (Trails B speed, p = 0.97 and errors, p = 0.93; Digit Span Backward length, p = 0.60), language (timed phonemic fluency, p = 0.05), and fine motor coordination/dexterity (Grooved Pegboard dominant hand time, p = 0.75 and peg drops, p = 0.59; nondominant hand time, p = 0.74 and peg drops, p = 0.61). Pearson Product Moment Correlations demonstrated significant (p < 0.001) associations between better neuropsychological performance and higher GOSE scores. Similar to the ProTECT III trial's results of the primary outcome, the secondary outcomes do not provide evidence of a neuroprotective effect of progesterone.

Keywords: adult brain injury; clinical trial; cognitive function; head trauma; prospective study.

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Conflict of interest statement

Author Disclosure Statement Dr. Wright reports receiving royalties from a patent related to progesterone for the treatment of patients with traumatic brain injury (U.S. patents 7,473,687, 7,915,244, and 8,455,468), which was licensed to BHR Pharma. For the remaining authors, no competing financial interests exist.

Figures

<b>FIG. 1.</b>
FIG. 1.
Reasons neurophsychologic measures not administered.
See this image and copyright information in PMC

Comment in

References

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