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

Traumatic Brain Injury Clinical Trial

— COBRIT  

Official title:

Citicoline Brain Injury Treatment Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00545662
• Other study ID #: BA-HD042
• Secondary ID: HD042687-04HD042
• Status: Terminated
• Phase: Phase 3
• First received: October 16, 2007
• Last updated: November 16, 2012
• Start date: July 2007
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1213
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Texas, Southwestern Medical Center	Dallas	Texas
United States	University of Tennessee Health Sciences Center	Memphis	Tennessee
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional and Cognitive Outcome	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.	90 days	No