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Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury (ABELADRUG200)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810940
Recruitment Status : Unknown
Verified December 2010 by Abela Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : December 18, 2008
Last Update Posted : December 8, 2010
Ohio State University
University of California, Irvine
Dr. Mahajan's Hospital & Industrial Trauma Centre
Information provided by:
Abela Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Severe Head Trauma Drug: AbelaDrug200 Drug: mannitol Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Study Start Date : October 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. reduction in intracranial pressure [ Time Frame: 24 hours, 5 days ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 3 months ]
  2. Glasgow Outcome Scale [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810940

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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

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Responsible Party: Colette Cozean, Ph.D., CEO, Abela Pharmaceuticals, Inc. Identifier: NCT00810940    
Other Study ID Numbers: AbelaTBI2
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010
Keywords provided by Abela Pharmaceuticals, Inc.:
closed head injury
severe head trauma
traumatic brain injury
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs