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

Last updated: November 16, 2012
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Overall Status: Terminated

Phase

3

Condition

Memory Loss

Traumatic Brain Injury

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00545662
BA-HD042
HD042689-05
HD042738-05
HD 042686-01A1
HD042652-04
HD042653-05
HD042678-03
HD042687-04
HD042823-05
HD042736-04
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Non-penetrating traumatic brain injury.

  2. Age 18 (19 in Alabama) - 70 years.

  3. GCS criteria on/off paralytics as specified in protocol

  4. Reasonable expectation of completion of outcomes measures at a network center at sixmonths post-injury.

  5. Able to swallow oral medication or, if unable to swallow, a gastric tube or peg areplaced by 23 hours after injury.

  6. Reasonable expectation of enrollment within 24-hour time window.

  7. English-speaking

Exclusion

Exclusion Criteria:

  1. Intubated patients with GCS motor score = 6 and not meeting CT criteria.

  2. Bilaterally fixed and dilated pupils

  3. Positive pregnancy test, known pregnancy, or currently breast feeding

  4. Evidence of diseases that interfere with outcome assessment

  5. Current acetylcholinesterase inhibitor use (Appendix 1)

  6. Imminent death or current life-threatening disease

  7. Currently enrolled in another study

  8. Prisoners

Study Design

Total Participants: 1213
Study Start date:
July 01, 2007
Estimated Completion Date:
May 31, 2011

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-3295
    United States

    Site Not Available

  • University of Maryland, Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Temple University

    Philadelphia, Pennsylvania 19141-3099
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213-3221
    United States

    Site Not Available

  • University of Tennessee Health Sciences Center

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • University of Texas, Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298-0677
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 23298-0631
    United States

    Site Not Available

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