OPTIMA-TBI Pilot Study

Summary

This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.

Timeline

Start

2017-09-12

Primary completion

2021-07-27

Completion

2021-07-27

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow accrual of patients, lack of financial resources”

registry analysis (superiority test); Omega-3 Polyunsaturated Fatty Acid Treatment Arm vs Placebo Arm; p = .24; Kruskal-Wallis NCT03345550 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omega-3 fatty acids	Unknown	1.2 g	—

Indications