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

Brain Injuries Clinical Trial

— INTREPID2566  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Study of NNZ-2566 in Patients With Traumatic Brain Injury (TBI) Conducted Under an Exception From Informed Consent (EFIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366820
• Other study ID #: Neu-2566-TBI-002
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2011
• Last updated: February 1, 2018
• Start date: February 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2018
• Source: Neuren Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

• QTc Exclusions. The study will use the exclusion criteria as defined in ICH Guideline E14 to exclude patients with a risk of QT/QTc prolongation, as follows:

• 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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Drug:
• 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.
• Placebo
Sodium Chloride 0.9% Injection

Locations

Country	Name	City	State
United States	Arrowhead Regional Medical Center	Colton	California
United States	Detroit Receiving Hospital and University Health Center	Detroit	Michigan
United States	Sinai Grace Hospital	Detroit	Michigan
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Neuren Pharmaceuticals Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced incidence, compared to placebo, of adverse events (AEs) and serious adverse events (SAEs)		AEs to discharged or Day 30 post randomization, whichever occurs first, and SAEs through to 3 months (defined as 12-14 weeks), post randomization.
Secondary	Evidence of efficacy in modifying global outcomes by evaluating Glasgow Outcome Scale - Extended (GOS-E) and activities of daily living (Mayo-Portland Adaptability Inventory - 4th Edition (MPAI-4))		1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks), post randomization.
Secondary	Improvement in cognitive and neuropsychological functioning.		1 month (defined as 4-6 weeks) and at 3 months (defined as 12-14 weeks), post randomization.
Secondary	Modification of the acute physiological processes in TBI by evaluating electroencephalographic (EEG) determinants in patients with moderate to severe TBI (defined as GCS 4-12), and biomarker levels.		Baseline through to 72 hours post-start of infusion.
Secondary	Blood pharmacokinetics (PK) of an intravenous (i.v) dose of NNZ-2566 when administered as a 10-minute infusion immediately followed by a 72-hour infusion.		Start of infusion through to 12 hours post infusion.