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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease
Neurology, Volume 66, No. 5, Year 2006
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Description
Background: Creatine and minocycline were prioritized for testing in Phase II clinical trials based on a systematic evaluation of potentially disease modifying compounds for Parkinson disease (PD). Objective: To test whether creatine and minocycline alter the course of early PD relative to a predetermined futility threshold for progression of PD in a randomized, double-blind, Phase II futility clinical trial. Agents that do not perform better than the futility threshold are rejected as futile and are not considered for further study. Methods: Participants had a diagnosis of PD within 5 years, but did not require medications for the management of symptoms. The primary outcome was the change in the total Unified Parkinson’s Disease Rating Scale (UPDRS) score from baseline to either the time when there was sufficient disability to warrant symptomatic therapy for PD or 12 months, whichever came first. Subjects were randomized 1:1:1 to receive creatine 10 g/day, minocycline 200 mg/day, or matching placebo. The futility threshold was set as a 30% reduction in UPDRS progression based on the placebo/tocopherol arm of the Deprenyl And Tocopherol Antioxidative Therapy Of Parkinsonism (DATATOP) trial. p Values ≤ 0.1 indicate futility. Results: Two hundred subjects were randomized to the three groups. Neither creatine (p = 0.96) nor minocycline (p = 0.66) could be rejected as futile based on the DATATOP futility threshold. The rate of progression for the calibration placebo group fell outside the 95% CI for the DATATOP historical control. In a sensitivity analysis, based on the threshold derived from the calibration placebo group, again neither drug could be rejected as futile. Tolerability was 91% in the creatine group and 77% in the minocycline group. Common adverse events included upper respiratory symptoms (26%), joint pain (19%), and nausea (17%). Conclusions: Both creatine and minocycline should be considered for definitive Phase III trials to determine if they alter the long term progression of Parkinson disease (PD). Additional factors must be weighed before selecting agents for Phase III trials, including safety, tolerability, activity, cost, and availability of these two agents in comparison with other agents currently in development for PD. © 2006 by AAN Enterprises, Inc.
Authors & Co-Authors
Kieburtz, Karl D.
United States, Rochester
University of Rochester
Tanner, Caroline M.
United States, Sunnyvale
Parkinson's Institute
Racette, Brad A.
United States, St. Louis
Washington University School of Medicine in St. Louis
Carter, Julie H.
United States, Portland
Oregon Health & Science University
Manyam, Bala V.
United States, Temple
Scott and White
Nance, Martha A.
United States, Minneapolis
Struthers Parkinson's Center
Hauser, Robert A.
United States, Tampa
University of South Florida, Tampa
Dawson, Ted M.
United States, Baltimore
Johns Hopkins University
Pahwa, Rajesh
United States, Kansas City
University of Kansas Medical Center
Lyons, Kelly E.
United States, Kansas City
University of Kansas Medical Center
Martin, W. R. Wayne
Canada, Edmonton
Glenrose Rehabilitation Hospital
Hunter, Christine B.
United States, Houston
Baylor College of Medicine
Adler, Charles H.
United States, Scottsdale
Mayo Clinic Scottsdale-phoenix, Arizona
Uitti, Ryan J.
United States, Jacksonville
Mayo Clinic in Jacksonville, Florida
Bower, James H.
United States, Rochester
Mayo Clinic in Rochester, Minnesota
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 Medical Center
Fagan, Susan C.
United States, Athens
University of Georgia
Statistics
Citations: 368
Authors: 19
Affiliations: 47
Identifiers
Doi:
10.1212/01.wnl.0000201252.57661.e1
ISSN:
00283878
Research Areas
Disability
Study Design
Case-Control Study