Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Choline; Cytidine Diphosphate Choline

Criteria

Inclusion Criteria:

1. Non-penetrating traumatic brain injury.

2. Age 18 (19 in Alabama) - 70 years.

3. GCS criteria on/off paralytics as specified in protocol

4. Reasonable expectation of completion of outcomes measures at a network center at six months post-injury.

5. Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury.

6. Reasonable expectation of enrollment within 24-hour time window.

7. English-speaking

Exclusion Criteria:

1. Intubated patients with GCS motor score = 6 and not meeting CT criteria.

2. Bilaterally fixed and dilated pupils

3. Positive pregnancy test, known pregnancy, or currently breast feeding

4. Evidence of diseases that interfere with outcome assessment

5. Current acetylcholinesterase inhibitor use (Appendix 1)

6. Imminent death or current life-threatening disease

7. Currently enrolled in another study

8. Prisoners