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

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.

Conditions

• Traumatic Brain Injury

Interventions

DRUG

Placebo

Drug Placebo Inactive twice a day given orally or enterally. The first dose is given within 24 hours of injury and treatment continues until 90 days or until the 90-day outcome assessment.

DRUG

citicoline

1000 mg twice a day orally or enterally. The first dose is within 24 hours of injury and treatment continues for 90-days or until the 90-day outcome assessment.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  lead NIH

Principal Investigators

• Sherry Melton, MD · University of Alabama at Birmingham

• Howard Eisenberg, MD · University of Maryland, Baltimore

• Jack Jallo, MD, PhD · Temple University

• Joseph Ricker, PhD · University of Pittsburgh

• Shelly Timmons, MD, PhD · University of Tennessee Health Sciences Center

• Ramon Diaz-Arrastia, MD, PhD · University of Texas Southwestern Medical Center

• John Ward, MD · Virginia Commonwealth University

• Nancy Temkin, PhD · University of Washington

• Beth Ansel, PhD · National Institute of Child Health and Human Development, National Center for Medical Rehabilitation Research

• William Friedewald, MD · Columbia University Department of Biostatistics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2011-05-31

Completion

2011-05-31

Countries

• United States

Study Locations