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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.

Publication ,  Journal Article
Elm, JJ; NINDS NET-PD Investigators,
Published in: Mov Disord
October 2012

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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Published In

Mov Disord

DOI

EISSN

1531-8257

Publication Date

October 2012

Volume

27

Issue

12

Start / End Page

1513 / 1521

Location

United States

Related Subject Headings

  • United States
  • Statistics, Nonparametric
  • Severity of Illness Index
  • Quality of Life
  • Parkinson Disease
  • Outcome Assessment, Health Care
  • Neurology & Neurosurgery
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Middle Aged
  • Male
 

Citation

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Elm, Jordan J., and Jordan J. NINDS NET-PD Investigators. “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.Mov Disord 27, no. 12 (October 2012): 1513–21. https://doi.org/10.1002/mds.25175.
Elm, Jordan J., and Jordan J. NINDS NET-PD Investigators. “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.Mov Disord, vol. 27, no. 12, Oct. 2012, pp. 1513–21. Pubmed, doi:10.1002/mds.25175.
Journal cover image

Published In

Mov Disord

DOI

EISSN

1531-8257

Publication Date

October 2012

Volume

27

Issue

12

Start / End Page

1513 / 1521

Location

United States

Related Subject Headings

  • United States
  • Statistics, Nonparametric
  • Severity of Illness Index
  • Quality of Life
  • Parkinson Disease
  • Outcome Assessment, Health Care
  • Neurology & Neurosurgery
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Middle Aged
  • Male