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

This study has been terminated.
(Trial stopped due to futility.)
Sponsor:
Information provided by (Responsible Party):
William Friedewald, Columbia University
ClinicalTrials.gov Identifier:
NCT00545662
First received: October 16, 2007
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose
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.

Condition Intervention Phase
Traumatic Brain Injury
 Drug: Placebo
Drug: citicoline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citicoline Brain Injury Treatment Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Functional and Cognitive Outcome [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The primary outcome of this study was analyzed using a global statistic of the Network Core Battery. There were 9 scales: California Verbal Learning Test II (CVLT-II); Controlled Oral Word Association Test (COWAT); Digit Span (DS); Glasgow Outcome Scale Extended (GOSE); Processing Speed Index (PSI); Stroop Test 1 and 2 (ST1&2); and Trail Making Test part A and B (TMT parts A and B). Each scale was assigned cut-off for good outcome: GOSE>7, CVLT>36, PSI>85, TMT part A <42, TMT part B<138.1, DS>7.15, ST1<60.29, ST2<151.47, COWAT>32.5. Logistic regression was used to estimate the global OR.
Enrollment: 1213
Study Start Date: July 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Placebo tablets formulated to resemble the citicoline treatment.
 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.
Experimental: Citicoline
Experimental treatment administered orally or enterally depending upon whether the participant can swallow at 1,000 mg twice a day for 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.
Other Name: CDP-Choline, Cytidine 5-diphosphocholine, Somazina

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.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 six months post-injury.
  5. Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury.
  6. Reasonable expectation of enrollment within 24-hour time window.
  7. English-speaking

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545662

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3295
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19141-3099
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-3221
United States, Tennessee
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0677
United States, Washington
University of Washington
Seattle, Washington, United States, 23298-0631
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Sherry Melton, MD University of Alabama at Birmingham
Principal Investigator: Howard Eisenberg, MD University of Maryland
Principal Investigator: Jack Jallo, MD, PhD Temple University
Principal Investigator: Joseph Ricker, PhD University of Pittsburgh
Principal Investigator: Shelly Timmons, MD, PhD University of Tennessee Health Sciences Center
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD University of Texas Southwestern Medical Center
Principal Investigator: John Ward, MD Virginia Commonwealth University
Principal Investigator: Nancy Temkin, PhD University of Washington
Study Director: Beth Ansel, PhD National Institute of Child Health and Human Development, National Center for Medical Rehabilitation Research
Principal Investigator: William Friedewald, MD Columbia University Department of Biostatistics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: William Friedewald, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT00545662     History of Changes
Other Study ID Numbers: BA-HD042  HD042687-04  HD042738-05  HD042678-03  HD042653-05  HD042689-05  HD042736-04  HD 042686-01A1  HD042652-04  HD042823-05 
Study First Received: October 16, 2007
Results First Received: November 29, 2011
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
traumatic brain injury
cognition
behavioral outcome
functional outcome
 treatment
early intervention
citicoline

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Cytidine Diphosphate Choline
Nootropic Agents

ClinicalTrials.gov processed this record on September 28, 2016