FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4379520359> ?p ?o ?g. }

• W4379520359 endingPage "1888" @default.
• W4379520359 startingPage "1878" @default.
• W4379520359 abstract "Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment." @default.
• W4379520359 created "2023-06-07" @default.
• W4379520359 creator A5002159502 @default.
• W4379520359 creator A5004800197 @default.
• W4379520359 creator A5004881804 @default.
• W4379520359 creator A5008585936 @default.
• W4379520359 creator A5010431192 @default.
• W4379520359 creator A5013704257 @default.
• W4379520359 creator A5014965894 @default.
• W4379520359 creator A5019647985 @default.
• W4379520359 creator A5021350165 @default.
• W4379520359 creator A5037420575 @default.
• W4379520359 creator A5042253324 @default.
• W4379520359 creator A5043468202 @default.
• W4379520359 creator A5044959686 @default.
• W4379520359 creator A5053299487 @default.
• W4379520359 creator A5053393681 @default.
• W4379520359 creator A5054431790 @default.
• W4379520359 creator A5064612722 @default.
• W4379520359 creator A5068463426 @default.
• W4379520359 creator A5068774458 @default.
• W4379520359 creator A5070195374 @default.
• W4379520359 creator A5077177867 @default.
• W4379520359 creator A5084310851 @default.
• W4379520359 creator A5084364814 @default.
• W4379520359 date "2023-09-01" @default.
• W4379520359 modified "2023-09-30" @default.
• W4379520359 title "Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial" @default.
• W4379520359 cites W1540844020 @default.
• W4379520359 cites W1869228284 @default.
• W4379520359 cites W1934667251 @default.
• W4379520359 cites W1971502696 @default.
• W4379520359 cites W1971541966 @default.
• W4379520359 cites W1998384354 @default.
• W4379520359 cites W2001871254 @default.
• W4379520359 cites W2003687276 @default.
• W4379520359 cites W2008720843 @default.
• W4379520359 cites W2013255807 @default.
• W4379520359 cites W2014263842 @default.
• W4379520359 cites W2025548235 @default.
• W4379520359 cites W2033335157 @default.
• W4379520359 cites W2038306701 @default.
• W4379520359 cites W2074020222 @default.
• W4379520359 cites W2085165928 @default.
• W4379520359 cites W2099028265 @default.
• W4379520359 cites W2107565079 @default.
• W4379520359 cites W2195493635 @default.
• W4379520359 cites W2314689571 @default.
• W4379520359 cites W2316255286 @default.
• W4379520359 cites W2797732082 @default.
• W4379520359 cites W2944466104 @default.
• W4379520359 cites W2951017640 @default.
• W4379520359 cites W3008795745 @default.
• W4379520359 cites W3080967669 @default.
• W4379520359 cites W3173223243 @default.
• W4379520359 cites W4295334631 @default.
• W4379520359 cites W4367669578 @default.
• W4379520359 doi "https://doi.org/10.1089/neu.2023.0163" @default.
• W4379520359 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37279301" @default.
• W4379520359 hasPublicationYear "2023" @default.
• W4379520359 type Work @default.
• W4379520359 citedByCount "1" @default.
• W4379520359 countsByYear W43795203592023 @default.
• W4379520359 crossrefType "journal-article" @default.
• W4379520359 hasAuthorship W4379520359A5002159502 @default.
• W4379520359 hasAuthorship W4379520359A5004800197 @default.
• W4379520359 hasAuthorship W4379520359A5004881804 @default.
• W4379520359 hasAuthorship W4379520359A5008585936 @default.
• W4379520359 hasAuthorship W4379520359A5010431192 @default.
• W4379520359 hasAuthorship W4379520359A5013704257 @default.
• W4379520359 hasAuthorship W4379520359A5014965894 @default.
• W4379520359 hasAuthorship W4379520359A5019647985 @default.
• W4379520359 hasAuthorship W4379520359A5021350165 @default.
• W4379520359 hasAuthorship W4379520359A5037420575 @default.
• W4379520359 hasAuthorship W4379520359A5042253324 @default.
• W4379520359 hasAuthorship W4379520359A5043468202 @default.
• W4379520359 hasAuthorship W4379520359A5044959686 @default.
• W4379520359 hasAuthorship W4379520359A5053299487 @default.
• W4379520359 hasAuthorship W4379520359A5053393681 @default.
• W4379520359 hasAuthorship W4379520359A5054431790 @default.
• W4379520359 hasAuthorship W4379520359A5064612722 @default.
• W4379520359 hasAuthorship W4379520359A5068463426 @default.
• W4379520359 hasAuthorship W4379520359A5068774458 @default.
• W4379520359 hasAuthorship W4379520359A5070195374 @default.
• W4379520359 hasAuthorship W4379520359A5077177867 @default.
• W4379520359 hasAuthorship W4379520359A5084310851 @default.
• W4379520359 hasAuthorship W4379520359A5084364814 @default.
• W4379520359 hasBestOaLocation W43795203591 @default.
• W4379520359 hasConcept C126322002 @default.
• W4379520359 hasConcept C142724271 @default.
• W4379520359 hasConcept C168563851 @default.
• W4379520359 hasConcept C203092338 @default.
• W4379520359 hasConcept C204787440 @default.
• W4379520359 hasConcept C27081682 @default.
• W4379520359 hasConcept C2779134260 @default.
• W4379520359 hasConcept C2779319286 @default.
• W4379520359 hasConcept C2780596555 @default.
• W4379520359 hasConcept C2908647359 @default.

• next