Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)

Phase 3 Terminated 1213 enrolled Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury.

Timeline

Start: 2007-07
Primary completion: 2011-05
Completion: 2011-05

Outcome

Missed primary endpoint

Stopped: “Trial stopped due to futility.”

registry Control vs Treatment; p = 0.76; Odds Ratio (OR) 0.98 (95% CI 0.83 to 1.14) NCT00545662 ↗

paper the use of citicoline compared with placebo for 90 days did not result in improvement in functional and cognitive status. PMID 23168823 ↗

Publications

Zafonte RD, Bagiella E, Ansel BM, Novack TA, Friedewald WT, Hesdorffer DC, Timmons SD, Jallo J, Eisenberg H, Hart T, Ricker JH, Diaz-Arrastia R, Merchant RE, Temkin NR, Melton S, Dikmen SS. Effect of citicoline on functional and cognitive status among patients with traumatic brain injury: Citicoline Brain Injury Treatment Trial (COBRIT). JAMA. 2012 Nov 21;308(19):1993-2000. doi: 10.1001/jama.2012.13256.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Citicoline	Other / unclassified	1000 mg	Oral