Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Abela Pharmaceuticals, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ohio State University
University of California, Irvine
Dr. Mahajan's Hospital & Industrial Trauma Centre
Information provided by:
Abela Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00810940
First received: December 16, 2008
Last updated: December 6, 2010
Last verified: December 2010

December 16, 2008
December 6, 2010
October 2010
December 2011   (final data collection date for primary outcome measure)
reduction in intracranial pressure [ Time Frame: 24 hours, 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810940 on ClinicalTrials.gov Archive Site
  • mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Glasgow Outcome Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Head Trauma
  • Drug: AbelaDrug200
    IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP < 20 mmHg, then IV 100 ml same schedule for 24 hours
  • Drug: mannitol
    mannitol plus standard treatment
  • Active Comparator: 1
    Control: Standard treatment for severe head trauma including mannitol
    Intervention: Drug: mannitol
  • Experimental: 2
    Study drug plus standard treatment
    Intervention: Drug: AbelaDrug200
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
16 Years to 70 Years
No
United States
 
NCT00810940
AbelaTBI2
Yes
Colette Cozean, Ph.D., CEO, Abela Pharmaceuticals, Inc.
Abela Pharmaceuticals, Inc.
  • Ohio State University
  • University of California, Irvine
  • Dr. Mahajan's Hospital & Industrial Trauma Centre
Not Provided
Abela Pharmaceuticals, Inc.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP