Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
- Registration Number
- NCT00810940
- Lead Sponsor
- Abela Pharmaceuticals, Inc.
- 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 drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Diagnosis TBI
- GCS 4-8
- Age 16-70
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 AbelaDrug200 Study drug plus standard treatment 1 mannitol Control: Standard treatment for severe head trauma including mannitol
- Primary Outcome Measures
Name Time Method reduction in intracranial pressure 24 hours, 5 days
- Secondary Outcome Measures
Name Time Method Glasgow Outcome Scale 3 months mortality 3 months
Trial Locations
- Locations (3)
University of California, Irvine
🇺🇸Irvine, California, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Ohio State University
🇺🇸Columbus, Ohio, United States