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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Severe Head Trauma
 Drug: AbelaDrug200
Drug: mannitol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Resource links provided by NLM:

Drug Information available for: Mannitol
U.S. FDA Resources

Further study details as provided by Abela Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • reduction in intracranial pressure [ Time Frame: 24 hours, 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Glasgow Outcome Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Control: Standard treatment for severe head trauma including mannitol
 Drug: mannitol
mannitol plus standard treatment
Experimental: 2
Study drug plus standard treatment
 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

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810940

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92868
Contact: Michael Lekawa, MD     714-456-5396        
Principal Investigator: Michael Lekawa, MD            
United States, Massachusetts
Boston University Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: John McGregor, MD     614-293-5440        
Principal Investigator: John McGregor, MD            
Sponsors and Collaborators
Abela Pharmaceuticals, Inc.
Ohio State University
University of California, Irvine
Dr. Mahajan's Hospital & Industrial Trauma Centre
  More Information

No publications provided

Responsible Party: Colette Cozean, Ph.D., CEO, Abela Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00810940     History of Changes
Other Study ID Numbers: AbelaTBI2
Study First Received: December 16, 2008
Last Updated: December 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abela Pharmaceuticals, Inc.:
TBI
closed head injury
severe head trauma
traumatic brain injury

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Mannitol
Diuretics, Osmotic
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013