Controlled Trial of ABELADRUG200 in Closed, Severe Head I... | NCT00810940

Studies
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

NCT00810940

Sponsor

Abela Pharmaceuticals, Inc.

Status

Unknown status

Last Update Posted

Dec 8, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Severe Head Trauma

Interventions

AbelaDrug200
mannitol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Dec 16, 2008

First Posted Date

Dec 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2010

Last Update Posted Date

Dec 8, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Abela Pharmaceuticals, Inc.INDUSTRY

Collaborators

Name	Class
Ohio State University	OTHER
University of California, Irvine	OTHER
Dr. Mahajan's Hospital & Industrial Trauma Centre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Control: Standard treatment for severe head trauma including mannitol	Drug: mannitol
2	Experimental	Study drug plus standard treatment	Drug: AbelaDrug200

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AbelaDrug200	Drug	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	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in intracranial pressure		24 hours, 5 days

Secondary Outcomes

Measure	Description	Time Frame
mortality		3 months
Glasgow Outcome Scale		3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine	Recruiting	Irvine	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma
D016489	Head Injuries, Closed
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D014949	Wounds, Nonpenetrating

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008353	Mannitol

Ancestor Terms

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided