Dexanabinol in Severe Traumatic Brain Injury

Phase 3

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT00129857
• Lead Sponsor: Pharmos

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, disability and death. Sometimes surgery is needed. Unfortunately, the investigators have no medication to treat the bad effects of head trauma. Part of the brain damage is due to toxic chemicals (including one called glutamate) that are released by the damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and may protect the brain against uncontrollable swelling and death.

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 ability to block NMDA receptors and neuroinflammatory cascades in the same molecule. Dexanabinol scavenges free radicals, protects neurons from toxicity of free radical generators and inhibits lipopolysaccharide-induced production of prostaglandin E2, NO and TNF-a by macrophages in culture.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2004-09
• Status Verified: 2004-11
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-12
• Last Update Submitted: 2006-05-04
• Last Update Posted: 2006-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale Extended (GOSE) at 6 months

Secondary Outcome Measures

Name	Time	Method
GOSE at 3 months
Mortality rates at 10 days and 6 months
Intracerebral pressure during first 72 hours of trauma
Neuroworsening at 10 days
Quality of life