drugset / Trial / NCT00810940
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Phase 1/2
Unknown
30 enrolled
Abela Pharmaceuticals, Inc.
Dr. Mahajan's Hospital & Industrial Trauma Centre · collabOhio State University · collabUniversity of California, Irvine · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-12
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AbelaDrug200 | Unknown | 100 ml | Intravenous |
| Comparator | Mannitol | Diagnostic / imaging agent | — | — |