Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1
Identifieur interne : 000250 ( Pmc/Curation ); précédent : 000249; suivant : 000251Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1
Auteurs :Source :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2012.
Abstract
Based on the pre-clinical and the results of a phase 2 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 3 study of creatine (10 gm daily) in participants with early, treated PD, the Long-term Study – 1 (LS-1) is being conducted by the NINDS Exploratory Trials in Parkinson’s Disease (NET-PD) network. The study utilizes a global statistical test (GST) encompassing multiple clinical rating scales to provide a multidimensional assessment of disease progression.
A total of 1,741 PD participants from 45 sites in the U.S. and Canada were randomized 1:1 to either 10-gm 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 (10gm/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.
Url:
DOI: 10.1002/mds.25175
PubMed: 23079770
PubMed Central: 3481179
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: Pour aller vers cette notice dans l'étape Curation :000250
Links to Exploration step
PMC:3481179Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1</title></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23079770</idno><idno type="pmc">3481179</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481179</idno><idno type="RBID">PMC:3481179</idno><idno type="doi">10.1002/mds.25175</idno><date when="2012">2012</date><idno type="wicri:Area/Pmc/Corpus">000250</idno><idno type="wicri:Area/Pmc/Curation">000250</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1</title></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><idno type="e-ISSN">1531-8257</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">Based on the pre-clinical and the results of a phase 2 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.</p></sec><sec id="S2"><title>Methods</title><p id="P2">A randomized, multicenter, double-blind, parallel group, placebo controlled Phase 3 study of creatine (10 gm daily) in participants with early, treated PD, the Long-term Study – 1 (LS-1) is being conducted by the NINDS Exploratory Trials in Parkinson’s Disease (NET-PD) network. The study utilizes a global statistical test (GST) encompassing multiple clinical rating scales to provide a multidimensional assessment of disease progression.</p></sec><sec id="S3"><title>Results</title><p id="P3">A total of 1,741 PD participants from 45 sites in the U.S. and Canada were randomized 1:1 to either 10-gm 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.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">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 (10gm/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.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">8610688</journal-id><journal-id journal-id-type="pubmed-jr-id">5937</journal-id><journal-id journal-id-type="nlm-ta">Mov Disord</journal-id><journal-id journal-id-type="iso-abbrev">Mov. Disord.</journal-id><journal-title-group><journal-title>Movement disorders : official journal of the Movement Disorder Society</journal-title></journal-title-group><issn pub-type="ppub">0885-3185</issn><issn pub-type="epub">1531-8257</issn></journal-meta><article-meta><article-id pub-id-type="pmid">23079770</article-id><article-id pub-id-type="pmc">3481179</article-id><article-id pub-id-type="doi">10.1002/mds.25175</article-id><article-id pub-id-type="manuscript">NIHMS399428</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1</article-title></title-group><contrib-group><contrib contrib-type="author"><collab>The NINDS NET-PD Investigators</collab><xref rid="FN1" ref-type="author-notes">*</xref></contrib></contrib-group><author-notes><corresp id="FN1">Address for Correspondence: Jordan J. Elm, PhD, Medical University of South Carolina, Division of Biostatistics & Epidemiology, 135 Cannon St., Suite 303, PO Box 250835 Charleston, SC 29425, Phone (843) 876-1605, Fax (843) 876-1126, <email>elmj@musc.edu</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>17</day><month>8</month><year>2012</year></pub-date><pub-date pub-type="ppub"><month>10</month><year>2012</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>10</month><year>2013</year></pub-date><volume>27</volume><issue>12</issue><fpage>1513</fpage><lpage>1521</lpage><abstract><sec id="S1"><title>Background</title><p id="P1">Based on the pre-clinical and the results of a phase 2 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.</p></sec><sec id="S2"><title>Methods</title><p id="P2">A randomized, multicenter, double-blind, parallel group, placebo controlled Phase 3 study of creatine (10 gm daily) in participants with early, treated PD, the Long-term Study – 1 (LS-1) is being conducted by the NINDS Exploratory Trials in Parkinson’s Disease (NET-PD) network. The study utilizes a global statistical test (GST) encompassing multiple clinical rating scales to provide a multidimensional assessment of disease progression.</p></sec><sec id="S3"><title>Results</title><p id="P3">A total of 1,741 PD participants from 45 sites in the U.S. and Canada were randomized 1:1 to either 10-gm 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.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">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 (10gm/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.</p></sec></abstract><kwd-group><kwd>neuroprotection</kwd><kwd>Parkinson’s disease</kwd><kwd>clinical trial</kwd><kwd>creatine</kwd><kwd>global statistical test</kwd></kwd-group><funding-group><award-group><funding-source country="United States">National Institute of Neurological Disorders and Stroke : NINDS</funding-source><award-id>U01 NS043127 || NS</award-id></award-group></funding-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/JankovicV1/Data/Pmc/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000250 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd -nk 000250 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= JankovicV1
|flux= Pmc
|étape= Curation
|type= RBID
|clé= PMC:3481179
|texte= Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:23079770" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \
| NlmPubMed2Wicri -a JankovicV1
| This area was generated with Dilib version V0.6.19. |  |