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A Clinical Trial of Progesterone for Severe Traumatic Brain Injury
Open accessAbstract
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. (Funded by BHR Pharma; SYNAPSE ClinicalTrials.gov number, NCT01143064.).
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“Currently, no readily available treatment has proven to be effective for preventing or reversing the BBB damage after TBI in the clinical setting.”
From Increased miR-21-3p in Injured Brain Microvascular Endothelial Cells after Traumatic Brain Injury Aggravates Blood–Brain Barrier Damage by Promoting Cellular Apoptosis and Inflammation through Targeting MAT2B (2019) · cites this paper as [15]
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“Finally, the disappointing results of progesterone in Phase III clinical trials has called into question the importance of sex hormones in determining TBI outcome. 73,74”
From Sex Differences in Traumatic Brain Injury: What We Know and What We Should Know (2019) · cites this paper as [73]
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Translational Inefficiencies in Traumatic Brain Injury Research: Evidence From 94 399 Publications.
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Metadata
- Authors
- Skolnick, B. E., Maas, A. I., Narayan, R. K., van der Hoop, R. G., MacAllister, T., Ward, J. D., Nelson, N. R., & Stocchetti, N.
- Affiliations
- Hofstra University (US)
- University of Antwerp (BE)
- Virginia Commonwealth University (US)
- University of Milan (IT)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-12-25
- Volume
- 371
- Issue
- 26
- Pages
- 2467-2476
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2046037876
- Cited by
- 505
- References
- 29
- Citations by year
- 2026: 40 · 2025: 25 · 2024: 25 · 2023: 18 · 2022: 44 · 2021: 36 · 2020: 46 · 2019: 46 · 2018: 49 · 2017: 56 · 2016: 67 · 2015: 50 · 2014: 1
- FWCI
- 37.61
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Tampere University Institutional Repository (Tampere University) (publishedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Tampere University Institutional Repository (Tampere University) (submittedVersion)
- Funders
- Universitair Ziekenhuis Antwerpen
- Topics
- Health Sciences › Medicine › Clinical Neurology › Traumatic Brain Injury and Neurovascular Disturbances
- Health Sciences › Medicine › Clinical Neurology › Traumatic Brain Injury Research
- Health Sciences › Medicine › Emergency Medicine › Trauma and Emergency Care Studies
- Keywords
- progesterone, severe traumatic brain injury, Glasgow Outcome Scale, treatment efficacy, drug safety, neuroprotection
- MeSH terms
- Adolescent, Adult, Aged, Brain Injuries, Double-Blind Method, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Progesterone, Glasgow Coma Scale, Odds Ratio, Treatment Failure, Glasgow Outcome Scale, Young Adult, Intention to Treat Analysis
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