NCT00545662

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

Citicoline Brain Injury Treatment Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,213 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established in either the acute or post acute setting. Citicoline is a naturally occurring endogenous compound. This compound offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery after TBI. The primary goal of this study is to assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-10-17
• Last updated: 2012-12-19
• Results posted: 2012-12-19

Locations

8 sites across 1 country: United States