Status: Enrolling by invitation
Keywords: Cervical Spondylotic Myelopathy , Sodium Glutamate-Drug
IRB Number: 00049505
Specialty: Orthopaedic Surgery, Orthopaedic Surgery
Sub Specialties: Orthopaedic Spine Surgery,
This is a multi-center, prospective, double-blinded, randomized placebo-controlled clinical trial to evaluate if sodium-glutamate antagonist Riluzole in a dose of 50mg BID 14 days before the surgery and continuing for 28 days after the surgery is superior to placebo in patients with moderate and severe cervical spondylotic myelopathy undergoing surgical decompression.
CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord impairment worldwide. The pathophysiology of CSM involves static and dynamic compression of spinal cord which triggers ischemia and secondary cell death by a variety of mechanisms, which prominently include sodium influx and glutamatergic excitotoxicity. While there is emerging evidence from the recently completed AOSpineNA prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have substantial residual neurological impairment. Moreover, while surgery is relatively safe, approximately 3% of patients sustain a neurological complication, of which C5 root palsy is the most common adverse outcome. Given this background and compelling evidence from preclinical models of nontraumatic and traumatic spinal cord injury (SCI), there is a strong rationale to consider the potential benefit of adding a neuroprotective drug which targets sodium/glutamate excitoxicity to the treatment of patients with CSM undergoing surgical decompression. Riluzole, a potent sodium/glutamate antagonist has been widely studied in many models of neurotrauma and neurodegenerative disease. This drug is FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to CSM. Moreover, Riluzole is currently under investigation for traumatic SCI. Given this background, there is a strong rationale to consider studying the potential neurological benefits of Riluzole as an adjunctive treatment to surgical decompression in patients with CSM.