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 : 001201 ( Main/Merge ); précédent : 001200; suivant : 001202Design 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. Elm [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Innovation.
English descriptors
- KwdEn :
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.
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Pascal:12-0423945Le document en format XML
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Box 250635</s1><s2>Charleston, SC 29425</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Caroline du Sud</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0423945</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0423945 INIST</idno><idno type="RBID">Pascal:12-0423945</idno><idno type="wicri:Area/PascalFrancis/Corpus">000059</idno><idno type="wicri:Area/PascalFrancis/Curation">002C55</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000222</idno><idno type="wicri:doubleKey">0885-3185:2012:Elm J:design:innovations:and</idno><idno type="wicri:Area/Main/Merge">001201</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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</title><author><name sortKey="Elm, Jordan J" sort="Elm, Jordan J" uniqKey="Elm J" first="Jordan J." last="Elm">Jordan J. Elm</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Division of Biostatistics and Epidemiology, Medical University of South Carolina, 135 Cannon Street suite 303, P.O. Box 250635</s1><s2>Charleston, SC 29425</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Caroline du Sud</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term><term>Creatine</term><term>Innovation</term><term>Long term</term><term>Nervous system diseases</term><term>Neurological disorder</term><term>Parkinson disease</term><term>Statistical test</term><term>Stroke</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Trouble neurologique</term><term>Accident cérébrovasculaire</term><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Innovation</term><term>Long terme</term><term>Essai clinique</term><term>Créatine</term><term>Test statistique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Innovation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml: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.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Caroline du Sud</li></region></list><tree><country name="États-Unis"><region name="Caroline du Sud"><name sortKey="Elm, Jordan J" sort="Elm, Jordan J" uniqKey="Elm J" first="Jordan J." last="Elm">Jordan J. Elm</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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