Dexanabinol in Severe Traumatic Brain Injury

May 4, 2006 updated by: Pharmos

Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

860

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Glasgow Outcome Scale Extended (GOSE) at 6 months

Secondary Outcome Measures

Outcome Measure
Quality of life
GOSE at 3 months
Mortality rates at 10 days and 6 months
Intracerebral pressure during first 72 hours of trauma
Neuroworsening at 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmos

Investigators

  • Study Chair: Andrew Maas, M.D., Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

August 11, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 5, 2006

Last Update Submitted That Met QC Criteria

May 4, 2006

Last Verified

November 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-2000-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on Dexanabinol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe