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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129857
Enrollment
860
Registered
2005-08-12
Start date
2001-01-31
Completion date
2004-09-30
Last updated
2006-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

Sponsors

Pharmos
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Scale Extended (GOSE) at 6 months

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026