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Neuroprotective Agent Study: Creatine
Study Title:
A multicenter, double-blind, parallel group, placebo controlled study of creatine in subjects with treated Parkinson’s disease (NETPD LS-1)
Description:
The major goal of this clinical trial is to institute a multicenter study to evaluate the efficacy of neuroprotective agents in Parkinson’s disease. The study is in the third phase of the NETPD project, called LS-1. The aim of this phase is to determine if creatine slows the progression of the disease defined by a combination of cognitive, physical, and quality of life measures. Active treatment with creatine will be compared to placebo control.
The study began in 2007 and is currently in the follow-up phase of the trial. The project is funded by the National Institute of Neurological Disorders and Stroke (NINDS), which is part of the National Institutes of Health (NIH).
The NETPD group selected creatine based on their previous results from the NETPD FS-1 study sponsored by the NIH. This study investigated the safety and effectiveness of minocycline (an antibiotic) and creatine (a food supplement) as neuroprotective agents in people with early, untreated Parkinson’s disease and determined that creatine performed better than the futile threshold. The current study LS-1 intends to determine if there is any long term benefit.
**Please note - this study has been terminated. For more information please see the Statement on Termination here**
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Statement on the Termination of NET-PD LS-1 Study
On September 11, 2013, the NINDS stopped the NET-PD LS-1 study of creatine for treatment of early stage Parkinson's disease, acting on the recommendation of the study's Data Safety Monitoring Board (DSMB). During the most recent DSMB review, the results of an interim analysis showed that it was futile to complete the study because longer patient follow-up was not likely to demonstrate a statistically significant difference between creatine and placebo. To date, the investigators have not found any safety concerns related to creatine at dosages of 5 grams twice daily for up to 5 years of treatment. Site investigators and coordinators have informed participants of the study's closure and have encouraged each participant to schedule a final study visit.
The LS-1 study enrolled 1,741 patients with early Parkinson's disease at 52 sites throughout North America. Participants were randomized to receive either a highly purified form of creatine or matching placebo twice daily. Creatine is hypothesized to support and stabilize mitochondrial function and act as an antioxidant. Mitochondrial dysfunction and oxidative stress have both been implicated as contributors to Parkinson's disease.
The principal investigators are in the process of conducting a detailed analysis of the complete data set from the LS-1 study and plan to publish these results in a scientific journal in an expedited manner.
“This is one of the largest studies of Parkinson’s disease to date,” said Petra Kaufmann, M.D., NINDS Associate Director for Clinical Research. “This effort reflects a remarkable achievement of a group of investigators who were able to recruit and retain a large group of patients for up to five years, as well as the commitment of the Parkinson’s patient community to such studies. The results will be invaluable to the planning of future trials.”
“Although the finding of lack of benefit is disappointing, the work of the study investigators and participants throughout this long-term study reflects an impressive dedication to the goal of improving the lives of patients with Parkinson’s disease,” said Walter Koroshetz, M.D., Deputy Director of NINDS. “NINDS stands committed to fund discovery science and translational research to slow the progression of PD and we are encouraged by recent biological advances that have identified compelling new treatment strategies.
Last updated September 11, 2013
http://parkinsontrial.ninds.nih.gov/...ermination.htm