Study of NNZ-2566 in Patients With Traumatic Brain Injury

Completed · Phase 2 · Has a placebo group

Conditions studied: Brain Injuries

In brief

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

Key facts

Study ID

NCT00805818

Run by

Neuren Pharmaceuticals Limited

People needed

261

Starts

2010-04-01

Expected to finish

2016-01-01

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Non-penetrating TBI.
• Male.
• Age 18-70 years.
• Admission to hospital.
• Post resuscitation GCS 4-12.
• Have at least one reactive pupil.
• 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).

You may not qualify if…

• 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.
• 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).

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• University of Miami, Lois Pope Life Center — Miami, Florida, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States
• Detroit Receiving Hospital and University Health Center — Detroit, Michigan, United States
• Sinai Grace Hospital — Detroit, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of Cincinnati, Mayfield Clinic — Cincinnati, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• St Luke's University Hospital — Bethlehem, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Texas Health Harris Methodist Hospital Fort Worth — Fort Worth, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States
• University of Wisconsin, Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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