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Dexanabinol in Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129857
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : May 5, 2006
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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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Dexanabinol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury
Study Start Date : January 2001
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Glasgow Outcome Scale Extended (GOSE) at 6 months

Secondary Outcome Measures :
  1. GOSE at 3 months
  2. Mortality rates at 10 days and 6 months
  3. Intracerebral pressure during first 72 hours of trauma
  4. Neuroworsening at 10 days
  5. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129857

Sponsors and Collaborators
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Study Chair: Andrew Maas, M.D. Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland
Publications of Results:
Layout table for additonal information Identifier: NCT00129857    
Other Study ID Numbers: PH-2000-1
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: May 5, 2006
Last Verified: November 2004
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
HU 211
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents