A pilot clinical trial of creatine and minocycline in early parkinson disease: 18-month results

Authors

Karl Kieburtz, University of Rochester
Barbara Tilley, Medical University of South Carolina
Bernard Ravina, University of Rochester
Wendy R. Galpern, National Institutes of Health (NIH)
Kathleen Shannon, Rush University Medical Center
Caroline Tanner, Parkinson's Institute
G. Frederick Wooten, University of Virginia
Brad Racette, Washington University School of Medicine in St. Louis
Patricia Deppen, Washington University School of Medicine in St. Louis
Richard B. Dewey, UT Southwestern Medical School
Burton Scott, Duke University
Joanne Field, Duke University
Julie Carter, Oregon Health & Science University
Matthew Brodsky, Oregon Health & Science University
Pamela Andrews, Oregon Health & Science University
Bala Manyam, Texas A&M University
Jacqueline Whetteckey, Texas A&M University
Jayaraman Rao, LSU Health Sciences Center - New Orleans
Maureen Cook, LSU Health Sciences Center - New Orleans
Michael J. Aminoff, University of California, San Francisco
Chadwick Christine, University of California, San Francisco
Jessie Roth, University of California, San Francisco
Martha Nance, Struthers Parkinson's Center
Sotirios Parashos, Struthers Parkinson's Center
Susan Peterson, Struthers Parkinson's Center
Jeana Jaglin, Rush University Medical Center
Carlos Singer, University of Miami
Marian A. Perez, University of Miami
Anita Blenke, University of Miami
Robert Hauser, University of South Florida, Tampa
Theresa McClain, University of South Florida, Tampa
Summer Wolfrath, University of South Florida, Tampa

Document Type

Article

Abstract

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.

Publication Date

1-1-2008

Publication Title

Clinical Neuropharmacology

ISSN

03625664

E-ISSN

1537162X

Volume

31

Issue

3

First Page

141

Last Page

150

PubMed ID

18520981

Digital Object Identifier (DOI)

10.1097/WNF.0b013e3181342f32

Recommended Citation

Kieburtz, Karl; Tilley, Barbara; Ravina, Bernard; Galpern, Wendy R.; Shannon, Kathleen; Tanner, Caroline; Wooten, G. Frederick; Racette, Brad; Deppen, Patricia; Dewey, Richard B.; Scott, Burton; Field, Joanne; Carter, Julie; Brodsky, Matthew; Andrews, Pamela; Manyam, Bala; Whetteckey, Jacqueline; Rao, Jayaraman; Cook, Maureen; Aminoff, Michael J.; Christine, Chadwick; Roth, Jessie; Nance, Martha; Parashos, Sotirios; Peterson, Susan; Jaglin, Jeana; Singer, Carlos; Perez, Marian A.; Blenke, Anita; Hauser, Robert; McClain, Theresa; and Wolfrath, Summer, "A pilot clinical trial of creatine and minocycline in early parkinson disease: 18-month results" (2008). Neurology. 728.
https://scholar.barrowneuro.org/neurology/728