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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Keywords

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traumatic brain injury cognition behavioral outcome functional outcome treatment early intervention citicoline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo tablets formulated to resemble the citicoline treatment.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

citicoline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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CDP-Choline, Cytidine 5-diphosphocholine, Somazina

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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William Friedewald

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherry Melton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Howard Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Jack Jallo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Joseph Ricker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Shelly Timmons, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Health Sciences Center

Ramon Diaz-Arrastia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

John Ward, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Nancy Temkin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Beth Ansel, PhD

Role: STUDY_DIRECTOR

National Institute of Child Health and Human Development, National Center for Medical Rehabilitation Research

William Friedewald, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Department of Biostatistics

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

University of Tennessee Health Sciences Center

Memphis, Tennessee, United States

Site Status

University of Texas, Southwestern Medical Center

Dallas, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 23168823 (View on PubMed)