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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Abela Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
Ohio State University
University of California, Irvine
Dr. Mahajan's Hospital & Industrial Trauma Centre
Information provided by:
Abela Pharmaceuticals, Inc. Identifier:
First received: December 16, 2008
Last updated: December 6, 2010
Last verified: December 2010
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
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:

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

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

Secondary Outcome Measures:
  • mortality [ Time Frame: 3 months ]
  • Glasgow Outcome Scale [ Time Frame: 3 months ]

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


Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00810940

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

Responsible Party: Colette Cozean, Ph.D., CEO, Abela Pharmaceuticals, Inc. Identifier: NCT00810940     History of Changes
Other Study ID Numbers: AbelaTBI2
Study First Received: December 16, 2008
Last Updated: December 6, 2010

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

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 25, 2017