North American Clinical Trials Network for the Treatment of Spinal Cord Injury: goals and progress

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The North American Clinical Trials Network (NACTN) for the Treatment of Spinal Cord Injury is a consortium of 10 neurosurgery departments, a data management center, and a pharmacological center. The NACTN was established with the goal of bringing recent molecular and cell-based discoveries in neuroprotection and regeneration from the laboratory into clinical trials that optimize meaningful data outcomes and maximum safety to patients. The requirements of planning and executing clinical trials in spinal cord injury (SCI) and the steps that the NACTN has taken to address these requirements are discussed and illustrated in articles in this issue of the Journal of Neurosurgery: Spine. The progress that the NACTN has made in meeting these goals can be summarized as organizing a network of hospitals capable of enrolling a sufficient number of patients for conducting Phase I and II trials; creating a Data Management Center and a database of the natural history of recovery after SCI (at the time of this writing 485 patients were enrolled in the database); creating a database of the incidence and severity of complications that occur during acute and subacute treatment after SCI; developing a Pharmacological Center capable of performing pharmacokinetic and pharmacodynamic studies of therapeutic drugs; completing enrollment of 36 patients in NACTN's first clinical trial, a Phase I study of riluzole, a neuroprotective drug; and performing pharmacokinetic and pharmacodynamic studies of riluzole in acute SCI.

Abbreviations used in this paper:AIS = American Spinal Injury Association Impairment Scale; ASIA = American Spinal Injury Association; CTN = Clinical Trials Network; DMC = Data Management Center; NACTN = North American Clinical Trials Network; SCI = spinal cord injury; SCIM = Spinal Cord Independence Measure.
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Contributor Notes

Address correspondence to: Robert G. Grossman, M.D., Department of Neurosurgery, The Methodist Hospital, 6560 Fannin, Suite 944, Houston, Texas 77030. email: rgrossman@tmhs.org.Please include this information when citing this paper: DOI: 10.3171/2012.4.AOSPINE1294.
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    Grossman RGToups EGFrankowski RBurau KHowley SNACTN: building a clinical trials network for spinal cord injury. Fehlings MVaccaro ABoakye M: Essentials of Spinal Cord Injury New YorkThieme[in press]2012

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