Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Severe Head Trauma Clinical Trial

— ABELADRUG200  

Official title:

Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00810940
• Other study ID #: AbelaTBI2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 16, 2008
• Last updated: December 6, 2010
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2010
• Source: Abela Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Severe Head Trauma

Intervention

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
• mannitol
mannitol plus standard treatment

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	University of California, Irvine	Irvine	California

Sponsors (4)

Lead Sponsor	Collaborator
Abela Pharmaceuticals, Inc.	Dr. Mahajan's Hospital & Industrial Trauma Centre, Ohio State University, University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in intracranial pressure		24 hours, 5 days	No
Secondary	mortality		3 months	No
Secondary	Glasgow Outcome Scale		3 months	No