What it is:
NACTN is a network of nine clinical centers and a data management and a pharmacological center dedicated to validating best practices in the care of spinal cord injury (SCI) and carrying out clinical trials of the safety and efficacy of new therapies. NACTN is clinical and biostatistical infrastructure for testing new promising therapies, evaluating their efficacy, bringing them through the regulatory process, and if shown to improve outcome, incorporating them as standards of care. NACTN is the only established standing network for clinical trials for SCI in North America. It has been supported by the Department of Defense since 2006 and in July 2010 was awarded a new two-year contract for its continued expansion. Walter Reed Army Medical Center became a NACTN site in 2007 and the new award will enable other military hospitals to join.
What it has accomplished/what we have learned:
NACTN has established an SCI database characterizing spinal cord injuries. This database is being used to establish trajectories of recovery for defined injuries and to develop models to predict outcomes of recovery. As of June, 700 patients had been screened, 399 enrolled and data on 368 patients collected and entered.
NACTN has also organized a Neurological Outcome Assessment initiative (NOA), an international task force of scientists and clinicians to develop, test, and validate outcome measures to detect incremental improvements (Motor, Autonomic, Sensory and Pain) for use in clinical trials.
NACTN began its first clinical trial in March of this year, a Phase I safety study of the neuroprotective drug, Riluzole. As of this writing, 21 newly injured patients have been enrolled; a total of 36 will be needed to complete this initial study.
What are the next steps:
NACTN investigators have developed a rigorous process by which they review potential therapies and the basic science behind them and then reach consensus about which the network should test in trials of therapy.
NACTN continues to enroll acutely injured patients into its data registry and analyze myriad data points in order to share findings with the spinal cord field at large. Its first manuscript on the medical complications that accompany acute injury has been submitted for review and publication; others will follow shortly.
NACTN is preparing to expand beyond its present nine clinical sites, including bringing at least one new military hospital into the network.
Get additional information about the North American Clinical Trials Network (NACTN).