Skip to main content
OpenTrials
Completed

NCT Number: NCT00129857

Dexanabinol in Severe Traumatic Brain Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexanabinol

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pharmos

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Aug 12, 2005
Registry last updated
May 5, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.