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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease
Neurology, Volume 68, No. 1, Year 2007
Notification
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Description
OBJECTIVE: To determine if future studies of coenzyme Q10 and GPI-1485 in Parkinson disease (PD) may be warranted. METHODS: We conducted a randomized, double-blind, calibrated futility clinical trial of coenzyme Q10 and GPI-1485 in early untreated PD using placebo data from the DATATOP study to establish the futility threshold. RESULTS: The primary outcome measure (change in total Unified Parkinson's Disease Rating Scale scores over 1 year) did not meet the prespecified criteria for futility for either agent. Secondary analyses using calibration controls and other more recent placebo data question the appropriateness of the predetermined definition of futility, and suggest that a more restrictive threshold may be needed. CONCLUSIONS: Coenzyme Q10 and GPI-1485 may warrant further study in Parkinson disease, although the data are inconsistent. Additional factors (cost, availability of other agents, more recent data on placebo outcomes, other ongoing trials) should also be considered in the selection of agents for Phase III studies. ©2007 AAN Enterprises, Inc.
Authors & Co-Authors
Tanner, Caroline M.
United States, Sunnyvale
Parkinson's Institute
Watts, Ray L.
United States, Birmingham
The University of Alabama at Birmingham
Carter, Julie H.
United States, Portland
Oregon Health & Science University
Hauser, Robert A.
United States, Tampa
University of South Florida, Tampa
Suchowersky, Oksana
Canada, Calgary
University of Calgary
Racette, Brad A.
United States, St. Louis
Washington University School of Medicine in St. Louis
Jankovic, Joseph J.
United States, Houston
Baylor College of Medicine
Hunter, Christine B.
United States, Houston
Baylor College of Medicine
Wooten, Frederick
United States, Charlottesville
University of Virginia
Martin, W. R. Wayne
Canada, Edmonton
Glenrose Rehabilitation Hospital
Pahwa, Rajesh
United States, Lawrence
University of Kansas
Lyons, Kelly E.
United States, Lawrence
University of Kansas
Adler, Charles H.
United States, Scottsdale
Mayo Clinic Scottsdale-phoenix, Arizona
Nance, Martha A.
United States, Struthers
Struthers Parkinson's Center
Uitti, Ryan J.
United States, Jacksonville
Mayo Clinic in Jacksonville, Florida
Bower, James H.
United States, Rochester
Mayo Clinic in Rochester, Minnesota
Fernandez, Hubert H.
United States, Gainesville
University of Florida
Guimarães, Paulo P.
United States, Charleston
Medical University of South Carolina
Huang, Peng
United States, Charleston
Medical University of South Carolina
Goetz, Christopher G.
United States, Chicago
Rush University
Fagan, Susan C.
United States, Athens
University of Georgia
Statistics
Citations: 208
Authors: 21
Affiliations: 50
Identifiers
Doi:
10.1212/01.wnl.0000250355.28474.8e
ISSN:
00283878
Research Areas
Disability
Study Design
Randomised Control Trial