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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A pilot clinical trial of creatine and minocycline in early parkinson disease: 18-month results
Clinical Neuropharmacology, Volume 31, No. 3, Year 2008
Notification
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Description
Objective-To report an 18-month follow-up on creatine and minocycline futility study, the Neuroprotective Exploratory Trials in Parkinson Disease, Futility Study 1 (NET-PD FS-1). Background-The NET-PD FS-1 futility study on creatine and minocycline found neither agent futile in slowing down the progression of disability in Parkinson disease (PD) at 12 months using the prespecified futility threshold. An additional 6 months of follow-up aimed to assess safety and potential interactions of the study interventions with anti-parkinsonian therapy. Methods-Additional 6 months of follow-up in randomized, blinded phase II trial of creatine (dosage, 10 g/d) and minocycline (dosage, 200 mg/d) in subjects with early PD. Results-By 18 months, symptomatic treatment of PD symptoms was required in 61% of creatine, 62% of minocycline, and 60% of placebo-treated subjects. Study treatment was prematurely discontinued in 9%, 23%, and 6% of subjects in the creatine, minocycline, and placebo arms, respectively. Creatine and minocycline did not seem to adversely influence the response to symptomatic therapy nor increase adverse events. Conclusions-Data from this small, 18-month phase II trial of creatine and minocycline do not demonstrate safety concerns that would preclude a large, phase III efficacy trial, although the decreased tolerability of minocycline is a concern. © 2008 by Lippincott Williams & Wilkins.
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.
Unknown Affiliation
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: 158
Authors: 19
Affiliations: 47
Identifiers
Doi:
10.1097/WNF.0b013e3181342f32
ISSN:
03625664
Research Areas
Disability
Study Design
Cohort Study
Exploratory Study