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Brain InjuriesPhase 2INTREPID2566NCT00805818

Study of NNZ-2566 in Patients With Traumatic Brain Injury

A Phase 2 study testing NNZ-2566 in people with Brain Injuries, run by Neuren Pharmaceuticals Limited at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 70 years, men only
Conditions the study is for
Brain Injuries
What is being tested?
NNZ-2566
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
261 participants
Where
20 sitesUnited States
Study dates
Apr 2010to Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-penetrating TBI.
  • Male.
  • Age 18-70 years.
  • Admission to hospital.
  • Post resuscitation GCS 4-12.
  • Have at least one reactive pupil.
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  • Randomization within 7 hours of injury with the ability to receive investigational product within 8 hours of injury.
  • Hemodynamically stable after resuscitation (systolic blood pressure (SBP) >100 mm Hg).
  • Willing to undergo all neuropsychological and activities of daily living (ADL) testing (i.e. understand English, able to read, write, have sufficient motor dexterity and, be available for follow-up visits at 4-6 weeks and 12-14 weeks post injury).

Who cannot join

  • 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 in the opinion of the Investigator would interfere with or bias the assessment of efficacy. This includes the following: schizophrenia; bipolar disorder; major depressive disorder; post traumatic stress disorder (PTSD); generalized anxiety disorder; attention deficit hyperactivity disorder; neurodegenerative diseases (Alzheimer's, Parkinson's, Huntington's disease, vascular dementia, Diffuse Lewy Body Disease); stroke; brain tumor; multiple sclerosis (MS); seizure disorders; chronic pain disorder; alcoholism or substance abuse.
  • Significant non-central nervous system (CNS) injuries sustained at the time of the TBI that in the opinion of the Investigator would interfere with or bias the assessment of efficacy.
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  • Weight >150 kg.
  • Participation in another clinical trial within the previous 4 weeks.
  • Clinical state requiring greater than 6 L colloid or crystalloid fluid resuscitation prior to randomization.
  • Inability to obtain informed consent from legally acceptable representative.
  • 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).

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

  • St Luke's University Hospital

    Bethlehem, Pennsylvania, 18015

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • University of Cincinnati, Mayfield Clinic

    Cincinnati, Ohio, 45219

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Detroit Receiving Hospital and University Health Center

    Detroit, Michigan, 48201

  • Sinai Grace Hospital

    Detroit, Michigan, 48235

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Texas Health Harris Methodist Hospital Fort Worth

    Fort Worth, Texas, 76104

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • University of Miami, Lois Pope Life Center

    Miami, Florida, 33136

  • University of Wisconsin, Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • University of South Alabama

    Mobile, Alabama, 36617

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NNZ-2566 in Patients With Traumatic Brain Injury

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

Read the 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
Being tested
NNZ-2566, Placebo
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNZ-2566Drug

    Also called Glycyl-L-2-Methylprolyl-L-Glutamic Acid

    Solution for intravenous infusion.

    20 mg/kg intravenous bolus infusion over 10 minutes followed by a continuous intravenous infusion of 1, 3, or 6 mg/kg/h for a total of 72 consecutive hours.

  • PlaceboDrug

    Also called Sodium Chloride 0.9% Injection

    Sodium Chloride 0.9% Injection

Study groups in NCT00805818
Study groupRoleWhat they receive
NNZ-2566Experimental20 mg/kg intravenous bolus infusion over 10 minutes followed by a continuous intravenous infusion of 1 mg/kg/h (Cohort 1, n=20), 3 mg/kg/h (Cohort 2, n=20) or 6 mg/kg/h (Cohort 3, n=133) intravenous infusion for a total of 72 consecutive hours.
Receives: Drug: NNZ-2566
Sodium Chloride (0.9%) for InjectionPlacebo comparatorIntravenous bolus infusion over 10 minutes followed by a continuous intravenous infusion (Cohort 1, n=10), (Cohort 2, n=10) or (Cohort 3, n=67) intravenous infusion for a total of 72 consecutive hours.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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))

    Measured: 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks), post randomization.

  2. Improvement in cognitive and neuropsychological functioning.

    Measured: 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.

    Measured: 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.

    Measured: Start of infusion through to 12 hours post infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2008 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00805818
Sponsor's protocol ID
Neu-2566-TBI-001
Acronym
INTREPID2566
Status last verified
Feb 2018
First submitted
8 Dec 2008
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lee JW. The EEG Ictal-Interictal Continuum-A Metabolic Roar But a Whimper of a Functional Outcome. Epilepsy Curr. 2019 Jul-Aug;19(4):234-236. doi: 10.1177/1535759719855968. Epub 2019 Jun 14.

    PubMed 31198061

  • Lee H, Mizrahi MA, Hartings JA, Sharma S, Pahren L, Ngwenya LB, Moseley BD, Privitera M, Tortella FC, Foreman B. Continuous Electroencephalography After Moderate to Severe Traumatic Brain Injury. Crit Care Med. 2019 Apr;47(4):574-582. doi: 10.1097/CCM.0000000000003639.

    PubMed 30624278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNZ-2566 in people with Brain Injuries, run by Neuren Pharmaceuticals Limited at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00805818, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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