Funding Agency:

Neuron Pharmaceuticals, Inc. via United States of America Department of Defense (Grant No.W81XWH-08-2-0014)

Total Project Period:

5/1/10 - 6/30/13

Total Project Award:

$227,000

Principal Investigator:

David Okonkwo, MD, PhD

Co-Investigator:

Ava Puccio, PhD

Project Summary:

The objective of this dose-escalation study is to evaluate the safety, pharmacokinetics and preliminary evidence of the neuroprotective effect of NNZ-2566 in patients with moderate to severe TBI (GCS 4-12) when administered for a total of 72 hours commencing within eight hours post-injury.

The safety, efficacy and PK evaluations will be based on a comparison of the three NNS-2566 treated groups with matched placebo through to three months (defined as 12-14 weeks) post randomization.

See also: Randomized, Double-Blind, Placebo-Controlled, Study of NNZ-2566 in Patients with Traumatic Brain Injury (INTREPID) with waiver of consent