Dexanabinol in Severe Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129857
• Other study ID #: PH-2000-1
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2005
• Last updated: May 4, 2006
• Start date: January 2001
• Est. completion date: September 2004

Study information

• Verified date: November 2004
• Source: Pharmos
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• Dexanabinol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmos

References & Publications (1)

Maas AI, Murray G, Henney H 3rd, Kassem N, Legrand V, Mangelus M, Muizelaar JP, Stocchetti N, Knoller N; Pharmos TBI investigators. Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale Extended (GOSE) at 6 months
Secondary	GOSE at 3 months
Secondary	Mortality rates at 10 days and 6 months
Secondary	Intracerebral pressure during first 72 hours of trauma
Secondary	Neuroworsening at 10 days
Secondary	Quality of life