Status:
COMPLETED
Dexanabinol in Severe Traumatic Brain Injury
Lead Sponsor:
Pharmos
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures,...
Detailed Description
Dexanabinol is a synthetic, non-psychotropic cannabinoid derivative that because of its dextro-configuration is compatible with activation of cannabinoid receptors in the brain. It combines the abilit...
Eligibility Criteria
Inclusion
- Traumatic head injury within the last 6 hours
- Glasgow Coma Motor score of 2 to 5; severity requires intracranial pressure (ICP) monitoring
- Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable
- An informed consent
Exclusion
- Penetrating head injury
- Spinal cord injury
- Coma due to pure epidural hematoma with initial Glasgow Coma Scale (GCS) of =\> 12
- Previous major cerebral damage
- Concomitant severe conditions
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT00129857
Start Date
January 1 2001
End Date
September 1 2004
Last Update
May 5 2006
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