Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT) - Full Text View

Sponsor:	Columbia University
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00545662

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: citicoline	Phase III

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:

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Cytidine diphosphate choline

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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival, toxicity, rate of recovery, tests for disability, satisfaction with life and psychological well being. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1292
Study Start Date:	July 2007
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Control	Drug: citicoline Citicoline (also known as CDP-Choline) is a naturally occurring endogenous compound. Citicoline may have neuroprotective effects and may potentiate neuro-recovery which has led to the evaluation of it as treatment for both stroke and TBI in animal models and in human clinical trials.
Active Comparator: Treatment	Drug: citicoline Citicoline (also known as CDP-Choline) is a naturally occurring endogenous compound. Citicoline may have neuroprotective effects and may potentiate neuro-recovery which has led to the evaluation of it as treatment for both stroke and TBI in animal models and in human clinical trials.

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
Genders Eligible for Study:	Both
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

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

Columbia University

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

Additional Information:

NIH/NICHD/NCMRR TBI Clinical Trials Network website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	William Friedewald, M.D./ 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
Last Updated:	May 18, 2011
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:

Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

Wounds and Injuries
Cytidine Diphosphate Choline
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012