The objective of the second clinical trial was to confirm the clinical relevance of the biomarker. The study evaluated, for example, the presence in mild TBI, specificity to TBI and its time-related appearance after the injury.
Medicortex started in Q4/2017 a large clinical study in collaboration with two Finnish hospitals. Patients with a suspected TBI, patients with an orthopedic injury, and healthy controls were recruited in the study. The sample collection was completed in the beginning of 2019 (total of 69 subjects), and all the samples were analysed for the precence of the biomarker.
Sample analysis showed statistically significant increase in biomarker level.
More information about the study is available at ClinicalTrials.gov/NCT03306563.