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NCT00545662 · ClinicalTrials.gov registry record · Phase 3
Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)
A Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,213
- Enrollment target
NCT00545662: Clinical Trial Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00545662 is a Phase 3 study that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 1,213 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00545662, a Phase 3 study, was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,213 participants
- Enrollment target
Study 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.
Primary 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,
Interventions
- DRUG Placebo
- DRUG citicoline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,213 participants |
| Start Date | 2007-07 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Why NCT00545662 stopped before completion
NCT00545662 is an interventional study that assigns participants to a tested intervention. Its 1,213 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00545662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00545662 about?
NCT00545662 is a clinical study titled "Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)". 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.
What is the current status of trial NCT00545662?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,213 participants. The study started on 2007-07. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00545662?
The interventions under investigation include: Placebo (DRUG), citicoline (DRUG).
Who is sponsoring clinical trial NCT00545662?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00545662's enrollment target sits among peer trials
1,213 216th of 2000 higher than 1,785 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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