Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)
NCT00545662, Phase 3, Terminated, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2012-12-19
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT) | ClinicalTrials.gov |
| NCT number | NCT00545662 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 1,213 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury | ClinicalTrials.gov |
| Interventions | Placebo, citicoline | ClinicalTrials.gov |
| First posted | 2007-10-17 | ClinicalTrials.gov |
| Last updated | 2012-12-19 | ClinicalTrials.gov |
| Results first posted | 2012-12-19 | ClinicalTrials.gov |
Registered outcomes 1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Functional and Cognitive Outcome | 90 days | 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. | ClinicalTrials.gov |
Outcomes 1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Functional and Cognitive Outcome | 90 days | The analysis included both the patients with complete outcome data and those with at least one measure. Patients who died were also included in the analysis. | percentage of participants | NUMBER | ClinicalTrials.gov |
Results by group 18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Functional and Cognitive Outcome | Control | Glasgow Outcome Scale - Extended | 35.56 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Glasgow Outcome Scale - Extended | 35.43 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | California Verbal Learning Test | 60.48 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | California Verbal Learning Test | 57.71 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Processing Speed Index | 53.28 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Processing Speed Index | 52.68 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Trail Making A | 61.96 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Trail Making A | 64.96 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Trail Making B | 71.05 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Trail Making B | 74.44 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Digit Span | 84.02 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Digit Span | 86.50 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Stroop Task 1 | 67.95 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Stroop Task 1 | 65.31 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Stroop Task 2 | 66.59 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Stroop Task 2 | 68.29 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Control | Controlled Oral Word Association Test | 42.68 | percentage of participants | ClinicalTrials.gov | |
| Functional and Cognitive Outcome | Treatment | Controlled Oral Word Association Test | 37.32 | percentage of participants | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Control | 606 | ClinicalTrials.gov | |
| Overall Study | STARTED | Treatment | 607 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Control | 521 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Treatment | 528 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Control | 85 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Treatment | 79 | ClinicalTrials.gov |
Adverse events 42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Gastrointestinal | Gastrointestinal disorders | Control | 184 | 606 | ClinicalTrials.gov | |
| other | Gastrointestinal | Gastrointestinal disorders | Treatment | 193 | 607 | ClinicalTrials.gov | |
| other | Abnormal Lab | Investigations | Control | 143 | 606 | ClinicalTrials.gov | |
| other | Abnormal Lab | Investigations | Treatment | 175 | 607 | ClinicalTrials.gov | |
| other | Musculoskeletal | Musculoskeletal and connective tissue disorders | Control | 157 | 606 | ClinicalTrials.gov | |
| other | Musculoskeletal | Musculoskeletal and connective tissue disorders | Treatment | 132 | 607 | ClinicalTrials.gov | |
| other | Neurological | Nervous system disorders | Control | 319 | 606 | ClinicalTrials.gov | |
| other | Neurological | Nervous system disorders | Treatment | 308 | 607 | ClinicalTrials.gov | |
| other | Fever/Infection | Infections and infestations | Control | 118 | 606 | ClinicalTrials.gov | |
| other | Fever/Infection | Infections and infestations | Treatment | 127 | 607 | ClinicalTrials.gov | |
| other | Cardiovascular | Vascular disorders | Control | 88 | 606 | ClinicalTrials.gov | |
| other | Cardiovascular | Vascular disorders | Treatment | 86 | 607 | ClinicalTrials.gov | |
| other | Genitourinary | Renal and urinary disorders | Control | 73 | 606 | ClinicalTrials.gov | |
| other | Genitourinary | Renal and urinary disorders | Treatment | 75 | 607 | ClinicalTrials.gov | |
| other | Ophthalmologic | Eye disorders | Control | 51 | 606 | ClinicalTrials.gov | |
| other | Ophthalmologic | Eye disorders | Treatment | 48 | 607 | ClinicalTrials.gov | |
| other | Respiratory | Respiratory, thoracic and mediastinal disorders | Control | 132 | 606 | ClinicalTrials.gov | |
| other | Respiratory | Respiratory, thoracic and mediastinal disorders | Treatment | 143 | 607 | ClinicalTrials.gov | |
| other | Dermatologic/Skin | Skin and subcutaneous tissue disorders | Control | 69 | 606 | ClinicalTrials.gov | |
| other | Dermatologic/Skin | Skin and subcutaneous tissue disorders | Treatment | 59 | 607 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Control | ClinicalTrials.gov | ||
| Total, all-cause mortality | Treatment | ClinicalTrials.gov | ||
| Total, other adverse events | Control | 452 | 606 | ClinicalTrials.gov |
| Total, other adverse events | Treatment | 449 | 607 | ClinicalTrials.gov |
| Total, serious adverse events | Control | 117 | 606 | ClinicalTrials.gov |
| Total, serious adverse events | Treatment | 117 | 607 | ClinicalTrials.gov |
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs Control: serious adverse events | Trial comparisons |
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.