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Trial · Interventional

CompletedPhase 2Registry data

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

Short name INTREPID2566

NCTNCT01366820 (opens ClinicalTrials.gov in a new tab)Other idNeu-2566-TBI-002
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
261 participants (actual)
Sponsor
Neuren Pharmaceuticals Limited · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Feb 2013
Primary completion
Jan 2016
Completion
Jan 2016
First posted
6 Jun 2011 (estimated)
Last update posted
5 Feb 2018
Conditions
Brain Injuries

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 2

    INTREPID2566

    NCT01366820

    Feb 2013 to Jan 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • NNZ-2566Drug
  • PlaceboDrug

Arms2

  • Experimental

    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.

  • Placebo comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Reduced incidence, compared to placebo, of adverse events (AEs) and serious adverse events (SAEs)

    Time frame · 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 outcomes(4)

  1. 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))

    Time frame · 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks), post randomization.

  2. Improvement in cognitive and neuropsychological functioning.

    Time frame · 1 month (defined as 4-6 weeks) and at 3 months (defined as 12-14 weeks), post randomization.

  3. 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.

    Time frame · Baseline through to 72 hours post-start of infusion.

  4. 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.

    Time frame · Start of infusion through to 12 hours post infusion.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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