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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.

The NET-PD FS-ZONE Phase II trial has reached its conclusion. Patients are no longer being recruited or enrolled in this study.

Last updated September 11, 2013


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