Accession Number : ADA619447


Title :   Clinical Trials Network / Building Infrastructure to Accelerate Transfer of Basic Research in Spinal Cord Injury (SCI) to Clinical Practice


Descriptive Note : Annual rept. 1 May 2014-30 Apr 2015


Corporate Author : CHRISTOPHER REEVE FOUNDATION SHORT HILLS NJ


Personal Author(s) : Howley, Susan ; Grossman, Robert G ; Toups, Elizabeth


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a619447.pdf


Report Date : May 2015


Pagination or Media Count : 69


Abstract : NACTN is a clinical trials network that tests promising therapies for spinal cord injury (SCI) and maintains a patient registry that as of 5/12/15 has extensive data on 762 acutely injured patients; this is an ongoing study at all clinical centers. Registry data is available to non-NACTN scientists to facilitate the design of clinical trials. NACTN successfully conducted a Phase 1 safety study of the neuroprotective drug riluzole (Journal of Neurotrauma 31:239-255 (February 1, 2014) and in partnership with AOSpine North America (AOSNA) is participating in an international multi-center Phase 2/3 study to test the efficacy of riluzole in acute SCI. NACTN centers will conduct a pharmacology substudy within the Phase 2/3 trial that monitors changes in the drug's metabolism after SCI and correlates pharmacokinetics with outcome measures. NACTN is finalizing the DOD and local IRB regulatory requirements and anticipates that its sites will be fully engaged in the RISCIS and PK studies by year-end. The Riluzole in Acute Spinal Cord Injury Study (RISCIS): Rationale, Design and Critical Endpoints has been accepted for publication in the journal Spinal Cord. A NACTN/AOSNA supplement to the Journal of Neurosurgery: Spine, v17 was published September 1, 2012 in print and online (http://thejns.org/toc/spisup/17/1); the papers are based primarily on the Riluzole Phase 1 study and NACTN's SCI registry data.


Descriptors :   *CLINICAL TRIALS , *SPINAL CORD , *WOUNDS AND INJURIES , CLINICAL MEDICINE , COLLABORATIVE TECHNIQUES , DIAGNOSIS(MEDICINE) , KNOWLEDGE MANAGEMENT , MEDICAL RESEARCH , METABOLISM , NEUROSCIENCE , PATIENTS , PHARMACOKINETICS , PHARMACOLOGY , SPINAL COLUMN , THERAPY , TRAUMA


Subject Categories : Anatomy and Physiology
      Medicine and Medical Research
      Pharmacology


Distribution Statement : APPROVED FOR PUBLIC RELEASE