Status:
UNKNOWN
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Lead Sponsor:
Abela Pharmaceuticals, Inc.
Collaborating Sponsors:
Ohio State University
University of California, Irvine
Conditions:
Severe Head Trauma
Eligibility:
All Genders
16-70 years
Phase:
PHASE1
PHASE2
Brief 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 dru...
Eligibility Criteria
Inclusion
- Diagnosis TBI
- GCS 4-8
- Age 16-70
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00810940
Start Date
October 1 2010
End Date
December 1 2011
Last Update
December 8 2010
Active Locations (3)
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1
University of California, Irvine
Irvine, California, United States, 92868
2
Boston University Medical Center
Boston, Massachusetts, United States, 02118
3
Ohio State University
Columbus, Ohio, United States, 43210