Clinical Trial: Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Brief 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.
Detailed Summary:
Sponsor: Abela Pharmaceuticals, Inc.
Current Primary Outcome: reduction in intracranial pressure [ Time Frame: 24 hours, 5 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- mortality [ Time Frame: 3 months ]
- Glasgow Outcome Scale [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Abela Pharmaceuticals, Inc.
Dates:
Date Received: December 16, 2008
Date Started: October 2010
Date Completion: December 2011
Last Updated: December 6, 2010
Last Verified: December 2010
