Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Sponsor

Abela Pharmaceuticals, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00810940

Collaborator

Ohio State University (Other), University of California, Irvine (Other), Dr. Mahajan's Hospital & Industrial Trauma Centre (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

reduction in intracranial pressure [24 hours, 5 days]

Secondary Outcome Measures

mortality [3 months]
Glasgow Outcome Scale [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92868
2	Boston University Medical Center	Boston	Massachusetts	United States	02118
3	Ohio State University	Columbus	Ohio	United States	43210