Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02118 |
| Conditions: |
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Severe Head Trauma |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00810940 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02118
United States
There is no listed contact information for this specific location.
Site Status: Active, not recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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