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Study of Citicoline for the Treatment of Traumatic Brain Injury (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

October 16, 2007
November 16, 2012
July 2007
May 2011   (final data collection date for primary outcome measure)
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.
The primary outcome is a composite measure comprised of the following battery: CVLT II; COWAT; Digit Span; GOSE; Processing Speed Index; Stroop Test 1 and 2; and Trail Making Test part A and B. [ Time Frame: 90 days ]
Complete list of historical versions of study NCT00545662 on ClinicalTrials.gov Archive Site
Not Provided
Survival, toxicity, rate of recovery, tests for disability, satisfaction with life and psychological well being. [ Time Frame: 180 days ]
Not Provided
Not Provided
 
Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • 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.
    Other Name: CDP-Choline, Cytidine 5-diphosphocholine, Somazina
  • Experimental: Placebo
    Placebo tablets formulated to resemble the citicoline treatment.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: citicoline
Zafonte RD, Bagiella E, Ansel BM, Novack TA, Friedewald WT, Hesdorffer DC, Timmons SD, Jallo J, Eisenberg H, Hart T, Ricker JH, Diaz-Arrastia R, Merchant RE, Temkin NR, Melton S, Dikmen SS. Effect of citicoline on functional and cognitive status among patients with traumatic brain injury: Citicoline Brain Injury Treatment Trial (COBRIT). JAMA. 2012 Nov 21;308(19):1993-2000. doi: 10.1001/jama.2012.13256.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1213
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545662
BA-HD042, HD042687-04, HD042738-05, HD042678-03, HD042653-05, HD042689-05, HD042736-04, HD 042686-01A1, HD042652-04, HD042823-05
Yes
William Friedewald, Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Sherry Melton, MD University of Alabama at Birmingham
Principal Investigator: Howard Eisenberg, MD University of Maryland, Baltimore County
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP