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Efficacy and Safety of Dexanabinol in Severe Traumatic Brain Injury Deaxanabinol in Traumatic Brain Injury - Article


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Brain Injury

 



Clinical Trial: Efficacy and Safety of Dexanabinol in Severe Traumatic Brain Injury Deaxanabinol in Traumatic Brain Injury

This study has been completed.

Sponsored by: Pharmos
Information provided by: Pharmos
ClinicalTrials.gov Identifier: NCT00129857

Purpose

Each year a large number of patients are hospitalized at Shock Trauma centers with severe head injury.Bleeding into and swelling of these patients'''' brains may cause compression of vital structures, disability and death.Sometimes surgery is needed.Unfortunately, we 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 uncontrollaable swelling and daeth.
Condition Intervention Phase
Traumatic Brain Injury
  Drug: Dexanabinol
 Phase III

MedlinePlus related topics:  Head and Brain Injuries

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering from Severe Traumatic Brain Injury.

Further Study Details: 
Primary Outcomes: Glasgow Outcome Scale Extended (GOSE) at 6 months
Secondary Outcomes: GOSE at 3 months; Mortality Rates at 10 days ansd 6 months; Intracerebral Pressure during first 72 houirs of trauma.; Neuroworsening at 10 days; Quality of Life
Expected Total Enrollment:  860

Study start: January 2001;  Study completion: November 2004
Last follow-up: September 2004;  Data entry closure: November 2004

Dexanabinol is a synthetic, non-psychotropic cannabinod derivative that because 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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Traumatic head injury within the last 6 hrs.; Glasgow Coma Motor Score of 2 to 5;severity requires ICP monitoring;brain CT showing intracranial paranchymal abnormality and hemodynamically stable. An informed consent-

Exclusion Criteria:

Penetrating head injury Spinal cord injury Coma due to pure epidural hemayoma with initial GCS of=>12 Previous major cerebral damage - Concomtant Severe conditions

Location Information

Study chairs or principal investigators

Andrew Maas, M.D.,  Study Chair,  Dep. of Neurosurgery,Dijkzigt Hospital,Rotterdam, Holland   

More Information

Study ID Numbers:  PH-2000-1
Last Updated:  August 11, 2005
Record first received:  August 11, 2005
ClinicalTrials.gov Identifier:  NCT00129857
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005

Resources

  • Brain Injury (Centers for Disease Control and Prevention)
  • Brain Injury (National Institute of Neurological Disorders and Stroke)


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Page Updated: October 3, 2005
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