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

Primary Purpose

Severe Head Trauma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AbelaDrug200
mannitol
Sponsored by
Abela Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Head Trauma focused on measuring TBI, closed head injury, severe head trauma, traumatic brain injury

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, IrvineRecruiting
  • Boston University Medical Center
  • Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Control: Standard treatment for severe head trauma including mannitol

Study drug plus standard treatment

Outcomes

Primary Outcome Measures

reduction in intracranial pressure

Secondary Outcome Measures

mortality
Glasgow Outcome Scale

Full Information

First Posted
December 16, 2008
Last Updated
December 6, 2010
Sponsor
Abela Pharmaceuticals, Inc.
Collaborators
Ohio State University, University of California, Irvine, Dr. Mahajan's Hospital & Industrial Trauma Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00810940
Brief Title
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Acronym
ABELADRUG200
Official Title
Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Head Trauma
Keywords
TBI, closed head injury, severe head trauma, traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Control: Standard treatment for severe head trauma including mannitol
Arm Title
2
Arm Type
Experimental
Arm Description
Study drug plus standard treatment
Intervention Type
Drug
Intervention Name(s)
AbelaDrug200
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
mannitol
Intervention Description
mannitol plus standard treatment
Primary Outcome Measure Information:
Title
reduction in intracranial pressure
Time Frame
24 hours, 5 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
3 months
Title
Glasgow Outcome Scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lekawa, MD
Phone
714-456-5396
First Name & Middle Initial & Last Name & Degree
Michael Lekawa, MD
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John McGregor, MD
Phone
614-293-5440
First Name & Middle Initial & Last Name & Degree
John McGregor, MD

12. IPD Sharing Statement

Learn more about this trial

Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

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