Design innovations and baseline findings in a long-term Parkinson’s trial: NET-PD LS-1
Identifieur interne : 000250 ( Pmc/Corpus ); 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
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