NCT00129857

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2001

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
Last Updated

May 5, 2006

Status Verified

November 1, 2004

First QC Date

August 11, 2005

Last Update Submit

May 4, 2006

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Glasgow Outcome Scale Extended (GOSE) at 6 months

Secondary Outcomes (5)

  • 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

Interventions

DexanabinolDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Maas AI, Murray G, Henney H 3rd, Kassem N, Legrand V, Mangelus M, Muizelaar JP, Stocchetti N, Knoller N; Pharmos TBI investigators. Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, clinical trial. Lancet Neurol. 2006 Jan;5(1):38-45. doi: 10.1016/S1474-4422(05)70253-2.

    PMID: 16361021RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

HU 211

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Andrew Maas, M.D.

    Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

January 1, 2001

Study Completion

September 1, 2004

Last Updated

May 5, 2006

Record last verified: 2004-11