Nor Consult is the global CRO for this multi-center, double-blind, placebo controlled trial studying the safety and efficacy of the drug riluzole, sodium channel blocker, in the treatment of the secondary injuries associated with spinal cord injury. At this moment this is a cervical-spine research study with one of the largest world-wide approach. Currently there are 25 total research sites for the RISCIS trial, of which 23 are open for enrollment. Additional medical facilities are in various stages of the screening process in the United States, China, New Zealand, Germany, UK, and Middle East.
The study is co-sponsored by the U.S. Department of Defense, the Swiss-based non-profit AO Foundation, Rick Hansen Institute, Ontario Neurotrauma Foundation and the Christopher and Dana Reeve Foundation.
The Co-Principal Investigators are Dr. Robert Grossman, founder of the Grossman Lab at the Institute for Academic Medicine at Houston Methodist and Michael Fehlings, chairman of the spine program and the head of the Fehlings Laboratory at the University of Toronto.
More information on the RISCIS trial you can find on its page on its page on clinicaltrials.gov.
Nor Consult, LLC, is the CRO for the P-15 trial, a multi-center research effort assessing the p-15 bone putty in anterior cervical fusion with instrumentationUnder Nor Consult’s management, the trial was successfully completed in 2015 and the FDA allowed the client to skip the PMA panel review. The P-15 was approved and the trial is in post-approval follow-up phase. The Principal Investigator is Dr. Michael Jansen, Director at the Spine Education and Research Institute/Center of Spinal Disorders.
Nor Consult is the CRO for CSM-P, a randomized, double-blind, placebo-controlled multi-center studywhich has currently enrolled about 300 participants. Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord injury worldwide. While there is evidence that surgical decompression is an effective treatment for CSM, many patients will have remaining neurological impairment. Given this background and data from preclinical models of non-traumatic and traumatic spinal cord injury, there is strong evidence to consider the potential benefit of adding a neuroprotective drug which aids in the treatment of patients with CSM who are undergoing surgical decompression. Riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this background, there is a strong basis to consider studying the potential neurological benefits of Riluzole as a treatment to surgical decompression in patients with CSM.
Nor Consult is the CRO for the Phase IIB multi-center randomized controlled trial examining the efficacy of cerebrospinal fluid drainage. One of the goals of the CSFD trial in improving neurologic motor outcomes in patients with acute spinal cord injury.
The injury to the spinal cord occurs in two phases. The first phase is the primary physical damage and the secondary phase of the injury begins soon after it. Limiting tissue hypoperfusion post-injury can decrease the amount of damage. The purpose of this trial is to evaluate the safety and efficacy of cerebrospinal fluid drainage (CSFD) in its combination with elevation of mean arterial pressure (MAP), in comparison with MAP alone.
The research is funded by the U.S. Department of Defense. Nor Consult was actively involved in the study design and contributed to the successful grant application. The Principal Investigator is Dr. Nicholas Theodore, Director of Neurotrauma at Barrow Neurological Institute.
This clinical study is enrolling people suffering from Isthmic spondylolisthesis (IS) in multiple hospitals in the USA, Canada, and soon - in Australia. Symptoms of this spinal condition in which one vertebra slips forward over the vertebra below, are pain and spasm that create loss of function and impair quality of life. The most common surgical procedure for IS consists of an instrumented fusion of the affected level of the spine. Two types of surgical approaches are commonly used, from the front (anterior) and from the back side of the body (posterior). At this moment there are no evidence-based guidelines to help in choosing the surgical approach. The purpose of this study of Nor Consult, LLC, under sponsorship of AOSpine North America Research Network, is to compare effectiveness, complications, and costs of anterior versus posterior surgical approaches for IS. Principal Investigator for this trial is Paul Arnold, MD, of the University of Kansas Medical Center.