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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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Citicoline Brain Injury Treatment Trial |
Resource links provided by NLM:
Further study details as provided by William Friedewald, Columbia University:
Primary Outcome Measures:
- Functional and Cognitive Outcome [ Time Frame: 90 days ]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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Non-penetrating traumatic brain injury.
- Age 18 (19 in Alabama) - 70 years.
- GCS criteria on/off paralytics as specified in protocol
- Reasonable expectation of completion of outcomes measures at a network center at six months post-injury.
- Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury.
- Reasonable expectation of enrollment within 24-hour time window.
- English-speaking
Exclusion Criteria:
- Intubated patients with GCS motor score = 6 and not meeting CT criteria.
- Bilaterally fixed and dilated pupils
- Positive pregnancy test, known pregnancy, or currently breast feeding
- Evidence of diseases that interfere with outcome assessment
- Current acetylcholinesterase inhibitor use (Appendix 1)
- Imminent death or current life-threatening disease
- Currently enrolled in another study
- Prisoners
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00545662
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 |
Keywords provided by William Friedewald, Columbia University:
|
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 July 21, 2017