CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 270 enrolled
Drug / intervention
riluzole +1 moredrug
Likely dose
riluzole 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01257828
NCT01257828Phase 3Completed

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

AOSpine North America Research Network·interventional·Posted Dec 10, 2010·Updated Nov 2, 2018

In Brief

A Phase 3 clinical trial evaluating riluzole and Placebo medication for Cervical Spondylotic Myelopathy. Completed, enrolled 270 participants across 21 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2010
Enrollment StartMar 1, 2012
Primary CompletionDec 15, 2017
Study CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.6 years ago

Interventions

riluzoledrug

50mg BID orally for 14 days prior to surgery and 28 days after the surgery

Placebo medicationdrug

50mg BID orally for 14 days prior to surgery and 28 days after the surgery