Design innovations and baseline findings in a long‐term Parkinson's trial: The national institute of neurological disorders and stroke exploratory trials in Parkinson's Disease Long‐Term Study–1
Identifieur interne : 000607 ( Istex/Corpus ); précédent : 000606; suivant : 000608Design innovations and baseline findings in a long‐term Parkinson's trial: The national institute of neurological disorders and stroke exploratory trials in Parkinson's Disease Long‐Term Study–1
Auteurs : Jordan J. ElmSource :
- Movement Disorders [ 0885-3185 ] ; 2012-10.
English descriptors
Abstract
Based on the preclinical data and the results of a phase II futility study, creatine was selected for an efficacy trial in Parkinson's disease (PD). We present the design rationale and a description of the study cohort at baseline. A randomized, multicenter, double‐blind, parallel‐group, placebo‐controlled phase III study of creatine (10 g daily) in participants with early, treated PD, the Long‐term Study–1 (LS‐1), is being conducted by the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease network. The study utilizes a global statistical test (GST) encompassing five clinical rating scales to provide a multidimensional assessment of disease progression. A total of 1,741 PD participants from 45 sites in the United States and Canada were randomized 1:1 to either 10 g of creatine/day or matching placebo. Participants are being evaluated for a minimum of 5 years. The LS‐1 baseline cohort includes participants treated with dopaminergic therapy and generally mild PD. LS‐1 represents the largest cohort of patients with early treated PD ever enrolled in a clinical trial. The GST approach should provide high power to test the hypothesis that daily administration of creatine (10 g/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5‐year follow‐up visit against the background of dopaminergic therapy and best PD care. © 2012 Movement Disorder Society
Url:
DOI: 10.1002/mds.25175
Links to Exploration step
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<abstract lang="en">Based on the preclinical data and the results of a phase II futility study, creatine was selected for an efficacy trial in Parkinson's disease (PD). We present the design rationale and a description of the study cohort at baseline. A randomized, multicenter, double‐blind, parallel‐group, placebo‐controlled phase III study of creatine (10 g daily) in participants with early, treated PD, the Long‐term Study–1 (LS‐1), is being conducted by the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease network. The study utilizes a global statistical test (GST) encompassing five clinical rating scales to provide a multidimensional assessment of disease progression. A total of 1,741 PD participants from 45 sites in the United States and Canada were randomized 1:1 to either 10 g of creatine/day or matching placebo. Participants are being evaluated for a minimum of 5 years. The LS‐1 baseline cohort includes participants treated with dopaminergic therapy and generally mild PD. LS‐1 represents the largest cohort of patients with early treated PD ever enrolled in a clinical trial. The GST approach should provide high power to test the hypothesis that daily administration of creatine (10 g/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5‐year follow‐up visit against the background of dopaminergic therapy and best PD care. © 2012 Movement Disorder Society</abstract>
<note type="content">*Funding agencies: This study was sponsored by the National Institutes of Health, National Institute of Neurological Disorders and Stroke.</note>
<note type="content">*Relevant conflicts of interest/financial disclosure: Nothing to report.</note>
<note type="content">*Full financial disclosures and author roles may be found in the online version of this article.</note>
<subject lang="en"><genre>keywords</genre>
<topic>neuroprotection</topic>
<topic>Parkinson's disease</topic>
<topic>clinical trial</topic>
<topic>creatine</topic>
<topic>global statistical test</topic>
</subject>
<relatedItem type="host"><titleInfo><title>Movement Disorders</title>
</titleInfo>
<titleInfo type="abbreviated"><title>Mov. Disord.</title>
</titleInfo>
<genre type="journal">journal</genre>
<note type="content"> Additional Supporting Information may be found in the online version of this article.Supporting Info Item: Supporting Information - </note>
<subject><genre>article-category</genre>
<topic>Research Article</topic>
</subject>
<identifier type="ISSN">0885-3185</identifier>
<identifier type="eISSN">1531-8257</identifier>
<identifier type="DOI">10.1002/(ISSN)1531-8257</identifier>
<identifier type="PublisherID">MDS</identifier>
<part><date>2012</date>
<detail type="volume"><caption>vol.</caption>
<number>27</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>12</number>
</detail>
<extent unit="pages"><start>1513</start>
<end>1521</end>
<total>9</total>
</extent>
</part>
</relatedItem>
<identifier type="istex">959231ADE32D28779E411441F7FD5198E63C15C5</identifier>
<identifier type="DOI">10.1002/mds.25175</identifier>
<identifier type="ArticleID">MDS25175</identifier>
<accessCondition type="use and reproduction" contentType="copyright">Copyright © 2012 Movement Disorder Society</accessCondition>
<recordInfo><recordContentSource>WILEY</recordContentSource>
<recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin>
</recordInfo>
</mods>
</metadata>
<serie></serie>
</istex>
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