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

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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Head Trauma
• Intervention / Treatment: Drug: mannitol; Drug: AbelaDrug200

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • Recruiting
      • University of California, Irvine
      • Contact: Michael Lekawa, MD; Phone Number: 714-456-5396
      • Principal Investigator: Michael Lekawa, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Active, not recruiting
      • Boston University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: John McGregor, MD; Phone Number: 614-293-5440
      • Principal Investigator: John McGregor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Estimate): December 8, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: TBI; traumatic brain injury; closed head injury; severe head trauma
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma; Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: AbelaTBI2