NCT01257828

Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)

Efficacy of Riluzole in Patients With Cervical Spondylotic Myelopathy Undergoing Surgical Treatment. A Randomized, Double-Blind, Placebo-controlled Multi-Center Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: AOSpine North America Research Network · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cervical Spondylotic Myelopathy

Interventions

Type	Name	Description
DRUG	riluzole	50mg BID orally for 14 days prior to surgery and 28 days after the surgery
DRUG	Placebo medication	50mg BID orally for 14 days prior to surgery and 28 days after the surgery

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-12-15
• Completion: 2018-06-01
• First posted: 2010-12-10
• Last updated: 2018-11-02

Locations

21 sites across 2 countries: United States, Canada