Severe Head TraumaPhase 1/2ABELADRUG200NCT00810940
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
A Phase 1/2 study testing AbelaDrug200 and mannitol in people with Severe Head Trauma, run by Abela Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Severe Head Trauma
- What is being tested?
- AbelaDrug200 and mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 1/2
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis TBI
- GCS 4-8
- Age 16-70
Who cannot join
- Multiple trauma resulting in shock
- Bilateral absent pupil response
- Time from injury > 6 hours
- Brain tumor or mass effect secondary to hemorrhage or brain surgery
- Pregnancy
- Confounding condition or injury
- Spinal cord injury
- Sustained high blood pressure or arterial oxygen saturation
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Active, not recruiting
Boston University Medical Center
Boston, Massachusetts, 02118
- Recruiting
Ohio State University
Columbus, Ohio, 43210
John McGregor, MD, 614-293-5440
John McGregor, MD
- Recruiting
University of California, Irvine
Irvine, California, 92868
Michael Lekawa, MD, 714-456-5396
Michael Lekawa, MD
About this study
Official title: Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.
- Conditions
- Severe Head Trauma
- Being tested
- AbelaDrug200, mannitol
- Keywords
- TBI, closed head injury, severe head trauma, traumatic brain injury
- Medical subject headings
- Craniocerebral Trauma, Head Injuries, Closed, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbelaDrug200Drug
IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP < 20 mmHg, then IV 100 ml same schedule for 24 hours
mannitolDrug
mannitol plus standard treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Control: Standard treatment for severe head trauma including mannitol Receives: Drug: mannitol |
| 2 | Experimental | Study drug plus standard treatment Receives: Drug: AbelaDrug200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in intracranial pressure
Measured: 24 hours, 5 days
Secondary outcomes (2)
mortality
Measured: 3 months
Glasgow Outcome Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Head TraumaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abela Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University, University of California, Irvine, Dr. Mahajan's Hospital & Industrial Trauma Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810940
- Sponsor's protocol ID
- AbelaTBI2
- Acronym
- ABELADRUG200
- Status last verified
- Dec 2010
- First submitted
- 16 Dec 2008
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
- ClinicalTrials.gov ID
- NCT00810940
- Acronym / sponsor ID
- ABELADRUG200 / AbelaTBI2
- Conditions
- Severe Head Trauma
- Keywords
- TBI, closed head injury, severe head trauma, traumatic brain injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abela Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University, University of California, Irvine, Dr. Mahajan's Hospital & Industrial Trauma Centre
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 18 Dec 2008 (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.
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: mannitolControl: Standard treatment for severe head trauma including mannitol |
| 2 | Experimental | Drug: AbelaDrug200Study drug plus standard treatment |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis TBI
- GCS 4-8
- Age 16-70
Key exclusion criteria (8 listed)
- Multiple trauma resulting in shock
- Bilateral absent pupil response
- Time from injury > 6 hours
- Brain tumor or mass effect secondary to hemorrhage or brain surgery
- Pregnancy
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 |
|---|---|---|
| AbelaDrug200IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP < 20 mmHg, then IV 100 ml same schedule for 24 hours | Drug | 2 |
| mannitolmannitol plus standard treatment | Drug | 1 |
Primary outcome
reduction in intracranial pressure
Time frame: 24 hours, 5 days
2 secondary outcomes
mortality
Time frame: 3 months
Glasgow Outcome Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AbelaDrug200 and mannitol in people with Severe Head Trauma, run by Abela Pharmaceuticals, Inc. at 3 sites in United States.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in intracranial pressure (time frame: 24 hours, 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2010.