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
Results First Received: November 29, 2011  
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
Condition: Traumatic Brain Injury
Interventions: Drug: Placebo
Drug: citicoline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant were recruited from eight level I trauma centers: Virginia Commonwealth University; University of Maryland; Temple University; University of Tennessee; University of Alabama (Birmingham); University of Texas Southwestern (Dallas); University of Pittsburgh; University of Washington. Recruitment began on 7/23/2007 and ended on 2/4/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Control The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
Treatment Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.

Participant Flow:   Overall Study
    Control     Treatment  
STARTED     606     607  
COMPLETED     521     528  
NOT COMPLETED     85     79  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
Treatment Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
Total Total of all reporting groups

Baseline Measures
    Control     Treatment     Total  
Number of Participants  
[units: participants]
  606     607     1213  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     568     563     1131  
>=65 years     38     43     81  
Age  
[units: years]
Mean ± Standard Deviation
  41.1  ± 15.5     39.7  ± 16.2     40.4  ± 15.9  
Gender  
[units: participants]
     
Female     159     151     310  
Male     447     456     903  
Region of Enrollment  
[units: participants]
     
United States     606     607     1213  



  Outcome Measures

1.  Primary:   Functional and Cognitive Outcome   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information