Research Reports - A clinical trial of progesterone for severe traumatic brain injury

N Engl J Med. 2014 Dec 25;371(26):2467-76

Skolnick BE(1), Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, Nelson NR, Stocchetti N

BACKGROUND: Progesterone has been associated with robust positive effects in
animal models of traumatic brain injury (TBI) and with clinical benefits in two
phase 2 randomized, controlled trials. We investigated the efficacy and safety of
progesterone in a large, prospective, phase 3 randomized clinical trial.
METHODS: We conducted a multinational placebo-controlled trial, in which 1195
patients, 16 to 70 years of age, with severe TBI (Glasgow Coma Scale score, ≤8
[on a scale of 3 to 15, with lower scores indicating a reduced level of
consciousness] and at least one reactive pupil) were randomly assigned to receive
progesterone or placebo. Dosing began within 8 hours after injury and continued
for 120 hours. The primary efficacy end point was the Glasgow Outcome Scale score
at 6 months after the injury.
RESULTS: Proportional-odds analysis with covariate adjustment showed no treatment
effect of progesterone as compared with placebo (odds ratio, 0.96; confidence
interval, 0.77 to 1.18). The proportion of patients with a favorable outcome on
the Glasgow Outcome Scale (good recovery or moderate disability) was 50.4% with
progesterone, as compared with 50.5% with placebo. Mortality was similar in the
two groups. No relevant safety differences were noted between progesterone and
placebo.
CONCLUSIONS: Primary and secondary efficacy analyses showed no clinical benefit
of progesterone in patients with severe TBI. These data stand in contrast to the
robust preclinical data and results of early single-center trials that provided
the impetus to initiate phase 3 trials.

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