Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abela Pharmaceuticals, Inc.
• Collaborators: Dr. Mahajan's Hospital & Industrial Trauma Centre; Ohio State University; University of California, Irvine
• Treatments: Mannitol

Criteria

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