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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00545662

Run by

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

People needed

1213

Starts

2007-07-01

Expected to finish

2011-05-01

Last updated by the study team

2012-12-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-penetrating traumatic brain injury.
• Age 18 (19 in Alabama) - 70 years.
• GCS criteria on/off paralytics as specified in protocol
• Reasonable expectation of completion of outcomes measures at a network center at six months post-injury.
• Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury.
• Reasonable expectation of enrollment within 24-hour time window.
• English-speaking

You may not qualify if…

• Intubated patients with GCS motor score = 6 and not meeting CT criteria.
• Bilaterally fixed and dilated pupils
• Positive pregnancy test, known pregnancy, or currently breast feeding
• Evidence of diseases that interfere with outcome assessment
• Current acetylcholinesterase inhibitor use (Appendix 1)
• Imminent death or current life-threatening disease
• Currently enrolled in another study
• Prisoners

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Temple University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Tennessee Health Sciences Center — Memphis, Tennessee, United States
• University of Texas, Southwestern Medical Center — Dallas, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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