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

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

Baseline Characteristics

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 ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information