Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC

NCT ID: NCT01366820

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).

Detailed Description

Moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. There are currently no drugs available to reduce the brain damage or the persisting symptoms that result from TBI. The longer term goal of this study is to provide physicians with a safe and effective treatment for TBI

Conditions

Brain Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NNZ-2566

20 mg/kg intravenous bolus infusion of NNZ-2566 over 10 minutes followed by a continuous intravenous infusion of 6 mg/kg/h (n=133) intravenous infusion of NNZ-2566 for a total of 72 consecutive hours.

Group Type: EXPERIMENTAL

NNZ-2566

Intervention Type: DRUG

Solution for intravenous infusion.

Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours.

Sodium Chloride (0.9%) for Injection

Intravenous bolus infusion of Sodium Chloride (0.9%) for Injection over 10 minutes followed by a continuous intravenous infusion of Sodium Chloride (0.9%) for Injection for a total of 72 consecutive hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sodium Chloride 0.9% Injection

Interventions

NNZ-2566

Solution for intravenous infusion.

Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours.

Intervention Type: DRUG

Placebo

Sodium Chloride 0.9% Injection

Intervention Type: DRUG

Other Intervention Names

Glycyl-L-2-Methylprolyl-L-Glutamic Acid; Sodium Chloride 0.9% Injection

Eligibility Criteria

Inclusion Criteria

• Non-penetrating TBI.
• Age 16-75 years.
• Admission to hospital.
• Post resuscitation GCS 4-12.
• Have at least one reactive pupil.
• Able to receive investigational product within 8 hours of injury.
• Hemodynamically stable after resuscitation (systolic blood pressure (SBP) >100 mm Hg).
• Able to read and write English and have sufficient motor dexterity prior to injury to undertake the neuropsychological and activities of daily living (ADL) testing, in the opinion of the investigator, at 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks) post injury.

Exclusion Criteria

• Penetrating brain injury.
• Spinal cord injury.
• Presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
• Non-traumatic brain injury.
• Known history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
• Significant non-central nervous system (CNS) injuries sustained at the time of the TBI would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
• Weight >150 kg.
• Participation in another clinical trial within the previous 4 weeks.
• Clinical state requiring greater than 6 L blood, colloid or crystalloid fluid resuscitation prior to randomization.
• Pregnant or nursing mothers. Women of child-bearing potential must have a negative urine or blood test prior to randomization.
• Prior enrollment in this study.

• A marked baseline prolongation of corrected QT/QTc interval >450 ms.
• History of risk factors for torsade de pointes (e.g. heart failure, hypokalemia (serum potassium at screening <3.0 mmol/L)or family history of long QT syndrome).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuren Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross R Bullock, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami, Lois Pope Life Center

Locations

Arrowhead Regional Medical Center

Colton, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Detroit Receiving Hospital and University Health Center

Detroit, Michigan, United States

Sinai Grace Hospital

Detroit, Michigan, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

Neu-2566-TBI-002

Identifier Type: -

Identifier Source: org_study_id