Dexanabinol in Severe Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Pharmos
ClinicalTrials.gov Identifier:
NCT00129857
First received: August 11, 2005
Last updated: May 4, 2006
Last verified: November 2004
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: Dexanabinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Pharmos:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 860
Study Start Date: January 2001
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129857

Sponsors and Collaborators
Pharmos
Investigators
Study Chair: Andrew Maas, M.D. Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00129857     History of Changes
Other Study ID Numbers: PH-2000-1
Study First Received: August 11, 2005
Last Updated: May 4, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
HU 211
Dronabinol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 21, 2014