Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1
Identifieur interne : 000175 ( Main/Exploration ); précédent : 000174; suivant : 000176Design 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.
Descripteurs français
- Wicri :
- geographic : Canada, États-Unis.
English descriptors
- KwdEn :
- Aged, Antipsychotic Agents (therapeutic use), Canada, Creatine (therapeutic use), Double-Blind Method, Evidence-Based Medicine, Female, Humans, Longitudinal Studies, Male, Middle Aged, National Institute of Neurological Disorders and Stroke, Outcome Assessment (Health Care), Parkinson Disease (drug therapy), Parkinson Disease (psychology), Quality of Life, Severity of Illness Index, Statistics, Nonparametric, United States.
- MESH :
- chemical , therapeutic use : Antipsychotic Agents, Creatine.
- geographic : Canada, United States.
- drug therapy : Parkinson Disease.
- psychology : Parkinson Disease.
- Aged, Double-Blind Method, Evidence-Based Medicine, Female, Humans, Longitudinal Studies, Male, Middle Aged, National Institute of Neurological Disorders and Stroke, Outcome Assessment (Health Care), Quality of Life, Severity of Illness Index, Statistics, Nonparametric.
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
Affiliations:
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Le document en format XML
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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><affiliations><list></list><tree></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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