Title
Dexanabinol in Severe Traumatic Brain Injury
Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury
Phase
Phase 3Lead Sponsor
PharmosStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Traumatic Brain InjuryIntervention/Treatment
cannabidiol ...Study Participants
860Each 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.
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.
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
