NPF Statement About Halting of Creatine Study
Release date: 9/25/2013
The National Institute of Health (NIH) announced this month that they were halting the NET-PD LS-1 study because their statisticians found that creatine clearly did not offer a benefit for people with Parkinson’s disease. Creatine is sold as a nutritional supplement often bought by bodybuilders, and different studies disagreed on the effects on people with Parkinson’s. Creatine has an impact on mitochondria, the part of your cells that biologists think of as the power plant of the cell.
With our growing understanding of Parkinson’s, we now understand that there are many different ways that a person can develop Parkinson’s. Most of the therapies patients take today are ones that treat systems. The creatine study was one of the first studies of a therapy that treats cells. However, we also know that a neurologist can observe the same system problem (tremor, slowness, etc.) but that the underlying problem in the cells can be different. Creatine is a cellular treatment, and cellular treatments may need to be tailored to the individual, and not just given to everyone with Parkinson’s.
The study offers the potential to dig a little deeper into this: the investigators have amassed a lot of data on the participants, and we hope that as they sift through the data they will find out whether creatine offered a benefit to some patients and not others. We expect these results will be published soon and we will keep you updated. It is important to keep in mind that creatine has been used in Parkinson’s disease successfully to improve upper body strength: http://www.ncbi.nlm.nih.gov/pubmed/17312085
If you are taking creatine for your Parkinson’s disease and you feel it is helping you, you don’t have to stop. The study was not halted for safety reasons, and we do not believe that there is any danger to you. We recommend a follow-up with your study doctor if you are enrolled in this study, or follow-up with your regular doctor if you are taking creatine as an over-the-counter supplement.
Below is the official release from the National Institute of Neurological Disorders and Stroke (NINDS):
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.