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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:
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
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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
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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
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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 
Overall Participants Analyzed 
[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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    Control   Treatment
Total, other (not including serious) adverse events     
# participants affected / at risk   452/606 (74.59%)   449/607 (73.97%) 
Eye disorders     
Ophthalmologic †     
# participants affected / at risk   51/606 (8.42%)   48/607 (7.91%) 
Gastrointestinal disorders     
Gastrointestinal †     
# participants affected / at risk   184/606 (30.36%)   193/607 (31.80%) 
General disorders     
Diaphoresis †     
# participants affected / at risk   36/606 (5.94%)   28/607 (4.61%) 
Infections and infestations     
Fever/Infection †     
# participants affected / at risk   118/606 (19.47%)   127/607 (20.92%) 
Investigations     
Abnormal Lab †     
# participants affected / at risk   143/606 (23.60%)   175/607 (28.83%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal †     
# participants affected / at risk   157/606 (25.91%)   132/607 (21.75%) 
Nervous system disorders     
Neurological †     
# participants affected / at risk   319/606 (52.64%)   308/607 (50.74%) 
Renal and urinary disorders     
Genitourinary †     
# participants affected / at risk   73/606 (12.05%)   75/607 (12.36%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory †     
# participants affected / at risk   132/606 (21.78%)   143/607 (23.56%) 
Skin and subcutaneous tissue disorders     
Dermatologic/Skin †     
# participants affected / at risk   69/606 (11.39%)   59/607 (9.72%) 
Vascular disorders     
Cardiovascular †     
# participants affected / at risk   88/606 (14.52%)   86/607 (14.17%) 
Events were collected by systematic assessment



  Limitations and Caveats
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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
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