Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Severe Head Trauma

In brief

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.

Key facts

Study ID

NCT00810940

Run by

Abela Pharmaceuticals, Inc.

People needed

30

Starts

2010-10-01

Expected to finish

2011-12-01

Last updated by the study team

2010-12-08

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis TBI
• GCS 4-8
• Age 16-70

You may not qualify if…

• 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

Where it is running

• University of California, Irvine — Irvine, California, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Boston University Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.