Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.
| dc.contributor.author | Fehlings, Michael G | |
| dc.contributor.author | Pedro, Karlo M | |
| dc.contributor.author | Alvi, Mohammed Ali | |
| dc.contributor.author | Badhiwala, Jetan H | |
| dc.contributor.author | Ahn, Henry | |
| dc.contributor.author | Farhadi, H Francis | |
| dc.contributor.author | Shaffrey, Christopher I | |
| dc.contributor.author | Nassr, Ahmad | |
| dc.contributor.author | Mummaneni, Praveen | |
| dc.contributor.author | Arnold, Paul M | |
| dc.contributor.author | Jacobs, W Bradley | |
| dc.contributor.author | Riew, K Daniel | |
| dc.contributor.author | Kelly, Michael | |
| dc.contributor.author | Brodke, Darrel S | |
| dc.contributor.author | Vaccaro, Alexander R | |
| dc.contributor.author | Hilibrand, Alan S | |
| dc.contributor.author | Wilson, Jason | |
| dc.contributor.author | Harrop, James S | |
| dc.contributor.author | Yoon, S Tim | |
| dc.contributor.author | Kim, Kee D | |
| dc.contributor.author | Fourney, Daryl R | |
| dc.contributor.author | Santaguida, Carlo | |
| dc.contributor.author | Massicotte, Eric M | |
| dc.contributor.author | Huang, Peng | |
| dc.date.accessioned | 2024-08-08T22:08:33Z | |
| dc.date.available | 2024-08-08T22:08:33Z | |
| dc.date.issued | 2024-06 | |
| dc.description.abstract | ImportanceThe modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery.ObjectiveTo use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM.Design, setting, and participantsThis was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023.InterventionRiluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.Main outcomes and measuresThe primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE).ResultsOverall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007).Conclusions and relevanceIn this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes. | |
| dc.identifier | 2820238 | |
| dc.identifier.issn | 2574-3805 | |
| dc.identifier.issn | 2574-3805 | |
| dc.identifier.uri | ||
| dc.language | eng | |
| dc.publisher | American Medical Association (AMA) | |
| dc.relation.ispartof | JAMA network open | |
| dc.relation.isversionof | 10.1001/jamanetworkopen.2024.15643 | |
| dc.rights.uri | ||
| dc.subject | Cervical Vertebrae | |
| dc.subject | Humans | |
| dc.subject | Spinal Cord Diseases | |
| dc.subject | Riluzole | |
| dc.subject | Neuroprotective Agents | |
| dc.subject | Treatment Outcome | |
| dc.subject | Double-Blind Method | |
| dc.subject | Aged | |
| dc.subject | Middle Aged | |
| dc.subject | Female | |
| dc.subject | Male | |
| dc.subject | Spondylosis | |
| dc.title | Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial. | |
| dc.type | Journal article | |
| duke.contributor.orcid | Shaffrey, Christopher I|0000-0001-9760-8386 | |
| pubs.begin-page | e2415643 | |
| pubs.issue | 6 | |
| pubs.organisational-group | Duke | |
| pubs.organisational-group | School of Medicine | |
| pubs.organisational-group | Clinical Science Departments | |
| pubs.organisational-group | Orthopaedic Surgery | |
| pubs.organisational-group | Neurosurgery | |
| pubs.publication-status | Published | |
| pubs.volume | 7 |
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