Recruiting
Phase 1
Phase 2

ABELADRUG200

Sponsor:

Abela Pharmaceuticals, Inc.

Code:

NCT00810940

Conditions

Severe Head Trauma

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

AbelaDrug200

mannitol

Study Details

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.

Conditions

Severe Head Trauma

Study ID

NCT00810940

Start date

Oct, 2010

Status verified date

Dec, 2010

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Control: Standard treatment for severe head trauma including mannitol

experimental: 2

Study drug plus standard treatment

Interventions

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

mannitol

mannitol plus standard treatment

Primary outcome measure

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

Central Contacts and Locations

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92868

Contacts

Michael Lekawa, MD

714-456-5396

Principal Investigator:

Michael Lekawa, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

John McGregor, MD

614-293-5440

Principal Investigator:

John McGregor, MD

More Information

Sponsor

Abela Pharmaceuticals, Inc.

Last update posted

Dec 8, 2010

Last verified

Dec, 2010

Keywords

  • TBI
  • closed head injury
  • severe head trauma
  • traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abela Pharmaceuticals, Inc. on 2010-12-08.