Dexanabinol in Severe Traumatic Brain Injury

Pharmos

Status and phase

Completed

Phase 3

Conditions

Traumatic Brain Injury

Treatments

Drug: Dexanabinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00129857

PH-2000-1

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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