Traumatic Brain Injury Clinical Trial
Official title:
Citicoline Brain Injury Treatment Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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