Traumatic Brain InjuryPhase 3NCT00129857
Dexanabinol in Severe Traumatic Brain Injury
A Phase 3 study testing Dexanabinol in people with Traumatic Brain Injury, run by Pharmos.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Dexanabinol
- How many people
- 860 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Sep 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Dexanabinol
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexanabinolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJan 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 860 participants
Sponsor and investigators
- Lead sponsor
- Pharmos
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Maas, M.D., Study chair, Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129857
- Sponsor's protocol ID
- PH-2000-1
- Status last verified
- Nov 2004
- First submitted
- 11 Aug 2005
- Last updated
- 5 May 2006
- Results posted
- No
Publications
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.
PubMed 16361021
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00129857
- Acronym / sponsor ID
- PH-2000-1
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants
- Lead sponsor
- PharmosIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Sep 2004
- First posted
- 12 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexanabinol | Drug | – |
Primary outcome
Glasgow Outcome Scale Extended (GOSE) at 6 months
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2006.
- Results publication: PubMed 16361021Maas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Maas, M.D. study chair
Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexanabinol in people with Traumatic Brain Injury, run by Pharmos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extended (GOSE) at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2006.