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Mov Disord. 2012 Oct;27(12):1513-21. doi: 10.1002/mds.25175.

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.

Collaborators (419)

Kieburtz K, Tilley B, Babcock D, Galpern W, Hauser R, Kawai C, Racette BA, Ravina B, Reichwein S, Ross G, Shannon KM, Suchowersky O, Tanner CM, Roth JT, Watts RL, Walker H, Nicholas A, Stover N, Worrell J, Hauser R, Sanchez-Ramos J, Zesiewicz TA, McClain T, Burke D, Delgado H, Carter S, Piper G, Lowe P, Lew MF, Welsh M, Petzinger G, Togasaki D, Hui JS, Kawai C, Barles G, Juncos JL, Freeman A, Musante ML, Weeks, McGin L, McMurray R, Everhart G, Miyatake L, Sperin E, Wood-Siverio C, Carter J, Brodsky M, Andrews P, Crocker S, Jones A, Murray M, McCain C, Wilson A, Kerr K, Leehey M, Hall D, Bainbridge J, Johnson S, Egeberg M, Clark J, Mari Z, Dawson T, Marsh L, Savitt J, Dunlop B, Gerstenhaber M, McCoy A, Dewey RB Jr, O'suilleabhain P, Chitnis S, Hayward B, Johnson A, Gode A, Huet G, Carreon P, Aminoff MJ, Christine CW, Roth JT, DiMinno M, Fernandez H, Rodriguez R, Malaty I, Reback S, Brown G, Jemmott K, Neilson M, Smith-Bova A, Merritt S, Swartz C, Rizer K, Hastings E, Scott B, Stacy M, Field J, Grace K, Attix DK, Zweig R, Schwendimann RN, Hilliard C, Johnson L, Goudreau JL, Ackerman G, Russell D, Kathleen, Shannon M, Jaglin JA, Blasucci LM, Suchowersky O, Kraft S, Derwent L, Labelle N, Nance M, Parashos S, Wielinski C, Worley J, Peterson S, Ede P, Lenarz S, Siderowf A, Hurtig HI, Stern M, Colcher A, Horn S, Reichwein S, Tanner C, Tetrud J, Langston J, Brandabur M, Liang G, Huang NC, Stewart T, Ersted K, Smith K, Lawrence C, Bergman J, Reys L, Woods A, Brown A, Simon DK, Tarsy D, Paul L, Rose P, Silver A, Donovan S, Lim C, Miller J, Kraics L, Feigin A, Pourfar M, Shannon B, Marie M, Cox, Elble RJ, Young C, Kelley D, Chou K, Albin R, Wernette K, Wills AM, Sudarsky L, Hage G, Aronow-Werner SP, Singer C, Facca A, Gallo BV, Sengun C, Nahab F, Perez MA, Quesada M, Blenke A, Hinson V, Bergmann K, Revuelta G, Salak V, Zimmerman J, Delambo A, Ross W, Petrovitch H, Terashita S, Martin W, Camicioli R, McInnes G, Scott I, King P, Wieler M, Racette BA, Perlmutter JS, Tabbal S, Criswell S, Wright A, Deppen P, Ammel M, Pecoraro M, Wharton K, Shulman L, Weiner W, Reich S, Fishman P, Robottom B, Figari R, Cines M, Zappala N, Hamill R, Boyd J, Gardner J, Lenox S, Potter CA, Young J, Kenney S, Oesterle C, Ingvoldstad C, Waterman S, Lucy S, Simuni T, Videnovic A, Melen O, Zadikoff C, Williams K, Kuhta T, Ziehm E, Pahwa R, Lyons K, Parsons A, Gales T, Mack C, Ehlinger M, Cambi F, Slevin JT, Wagner R, Miara C, Gollomp S, Vernon GM, Raza S, Gollomp R, Spahr J, Coffey DJ, LeBlanc PR, Ostler T, Rao J, Felberg R, Oser F, Cook M, Marques C, Schaefer P, Carleton M, Bodis IG, Lytton W, Francois JD, Mayer T, Kavanagh P, Hajee M, Hayes E, Moffitt ZK, Glazman S, Schneider J, Liang TW, Sendek S, Barron T, Randazzo C, Jefferson T, Shahed J, Jankovic J, Ondo W, Kenney CJ, Adam O, Hunter C, Sethi K, Morgan JC, Farrow B, Jennings D, Marek K, Russell D, Tabamo R, Fussell B, Kelsey T, Behan J, Becker P, Leary L, Truong DD, Pathak M, Frei K, Tran AH, Tran M, Sombai J, Wooten G, Bennett J, Trugman J, Harrison MB, Rost-Ruffner E, Keller MF, Davis RB, Fang J, Phibbs F, Shearon D, Burns R, Dhall R, Ahmed A, Shill H, Thakur N, Moguel-Cobos G, Gostkowski M, Marlor LL, Gates D, Simpson E, Sage JI, Nieves A, Caputo D, Kosa E, Skidmore F, Coenen A, Dunn H, McCombs S, Roessner S, Sawka L, Huang Z, Smith L, Calhoun R, Wojcieszek J, Belden J, Price K, Hughes-Gay M, Dalvi A, Rezak M, Ro S, Kujawa K, Novak K, Vergenz S, Medalle G, Silvio S, Burau K, Ye R, Luo S, Weaver C, Lau G, Stoutenburg A, Wilson R, Shprecher D, Khadim L, Frasier D, Baker D, Olsen B, Bennett S, Harman J, Gardiner I, Goetz C, Ploth D, Gross CR, Bell KL, Chen DT, Foley R, Levy DE, Rodnitzky RL, Welch K, Beal M, Cummings JL, Edwards DJ, Fahn S, Levin B, Katz RG, Marin DB, Olanow C, Martin JC, DiEuliis D, Piantadosi S, Powers WJ, Wichman A, Babcock D, Galpern W, Marler J, Odenkirchen J, Elm JJ, Hauser R, Tilley BC, Kieburtz K, Aminoff MJ, Augustine E, Bennett S, Bodis-Wollner IG, Cambi F, Carter JH, Chou K, Christine CW, Dhall R, Dewey RB, Elble RJ, Fang J, Feigin A, Galpern W, Gardiner I, Harman J, Goudreau J, Juncos JL, Leehey M, Kamp C, Lew MF, Liang GS, Mari Z, Martin W, Nance M, Parashos S, Pahwa R, Lyons KE, Petrovitch H, Racette BA, Ravina B, Ross W, Sage JI, Shulman L, Simon DK, Simuni T, Singer C, Slevin JT, Suchowersky O, Tanner CM, Videnovic A, Voss TS, Walker H, Wills AM, Zweig R.

Author information

  • 1Division of Biostatistics and Epidemiology, Medical University of South Carolina, 135 Cannon Street, Suite 303, PO Box 250835, Charleston, SC 29425, USA. elmj@musc.edu

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.

Copyright © 2012 Movement Disorder Society.

PMID:
23079770
[PubMed - indexed for MEDLINE]
PMCID:
PMC3481179
Free PMC Article

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