Dexanabinol in Severe Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dexanabinol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andrew Maas, M.D.

Role: STUDY_CHAIR

Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland

References

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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.

Reference Type RESULT

PMID: 16361021 (View on PubMed)

Other Identifiers

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PH-2000-1

Identifier Type: -

Identifier Source: org_study_id