CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury worldwide. While there is evidence from the recently completed SpineNet prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have remaining neurological impairment. While surgery is relatively safe, approximately 3% of patients maintain a neurological problem. 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 whom 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
270
50mg BID orally for 14 days prior to surgery and 28 days after the surgery
50mg BID orally for 14 days prior to surgery and 28 days after the surgery
Barrow Neurological Institute
Phoenix, Arizona, United States
UC Davis Spine Center
Sacramento, California, United States
University of California - San Francisco
San Francisco, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Louisiana State University
Baton Rouge, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Orthopaedics
St Louis, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
...and 11 more locations
Modified Japanese Orthopedic Association Score (mJOA)
The mJOA is a clinician administered scale. It evaluates four clinical dimensions; motor dysfunction score for upper and lower extremities, sensation loss and sphincter dysfunction. The total score ranges from 0 (worst) to 18 (best).
Time frame: Before the surgery, 180 days
Nurick Score
Nurick score is a simple measure of neurological dysfunction and ranges from 0 (best) to 6 (worst).
Time frame: Pre-surgical, 180 days
SF-36v2.0
The SF36v2.0 is a health-related quality of life instrument that evaluates health status accross eight health dimensions.
Time frame: Before the surgery, 180 days
Neck Disability Index (NDI)
The NDI evaluates patient self-reported functional outcomes related to neck conditions. The NDI score ranges from 0 (best) to 100 (worst).
Time frame: Before the surgery, 180 days
Cervical Pain Numeric Rating Scale
Simple numeric rating scale with choises of answers from 0 (no pain) to 10 (worst imaginable pain)
Time frame: Before the surgery, 180 days
EQ-5D
EQ-5D™ is a standardised instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status.
Time frame: Before the surgery, 180 days
American Spinal Injury Association Score (ASIA)
The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.
Time frame: Before the surgery, 180 days
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