Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

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.

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