Halting of the Creatine Study
You can find out more about NPF's National Medical Director, Dr. Michael S. Okun, by also visiting the NPF Center of Excellence, University of Florida Center for Movement Disorders & Neurorestoration. Dr. Okun is also the author of the Amazon #1 Parkinson's Best Seller 10 Secrets to a Happier Life.
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.
Posted: 10/2/2013 11:54:46 AM by
Browse current and archived What's Hot in PD? articles, the National Parkinson Foundation's monthly blog for people with Parkinson's written by our National Medical Director, Dr. Michael S. Okun.
Deep Brain Stimulation for Parkinson’s Disease: NPF Congratulates Mahlon DeLong and Alim-Louis Benabid and Looks to a Bright Future in Human Neural-Network Modulation
Everything You Need to Know About Medical Marijuana and Parkinson’s Disease
The End for Levodopa Phobia: New Study Shows Sinemet is a Safe Initial Therapy for Treatment of Parkinson's Disease
Is light therapy a potential treatment modality in Parkinson’s disease?
How does the most common genetic cause of Parkinson’s Disease (LRRK2) cause Parkinson’s disease and could it be used to help develop a better therapy?
An Update on DAT Scanning for Parkinson’s Disease Diagnosis
Could Northera (Droxidopa) Be an Alternative Treatment for Low Blood Pressure and Passing Out Symptoms?
The Dream of a Pill Free Existence and the Continuous Dopaminergic Pump for the Treatment of Parkinson's Disease
Should I take Inosine to Raise my Uric Acid Levels and Treat my Parkinson’s Disease?
Could Fungus and Mold be an Important Contributor to Parkinson’s Disease?
Pimavanserin and the Hope for a Better Drug for Hallucinations and Psychosis in Parkinson’s Disease
Halting of the Creatine Study
The Importance of Identifying and Treating Caregiver Strain
Putting Parkinson’s Disease Information into the Palm of Your Hand: Parkinson’s Enters the Smartphon
What Parkinson’s Disease Patients Need to Know about H. Pylori Gastrointestinal Infections
A2A Receptor Antagonists and Parkinson’s Disease Treatment
Another Setback for Trophic Factor Treatment in Parkinson's Disease
IPX066 and What Patients Really Want in New Carbidopa/Levodopa (Sinemet) Formulations
The Weather Forecast for Parkinson’s Disease Calls for Worldwide Economic Storm
Defeating the Barriers to Implementing Exercise Regimens in Parkinson’s Disease Patients
When should you start medication therapy for Parkinson’s disease?
Neurologist Care Reduces Hospitalizations in Parkinson's Disease
A Victory in Court for Parkinson's Disease Patients who Require Ongoing Rehabilitative Therapies
Given the recent FDA announcement about Mirapex (pramipexole), should I be worried about dopamine agonists?
What about the new Parkinson’s Disease Vaccine? What should I know?
Caffeine as a Potential Treatment for Parkinson’s Disease
Time to Consider GPi DBS for Parkinson’s Disease: A Shift in the Practice of Patient Selection for DBS
A New Treatment for Parkinson’s Disease-Related Constipation
Too Many Pills: Improving Delivery Systems for Parkinson’s Disease Drugs
Measuring Quality and Assessing Depression in Parkinson's Disease
Watch out for Unexpected Obstacles if You Use a Cueing Strategy to Break Freezing of Gait in Parkinson’s Disease
Pill Color, Generic Medications and Insurance Issues: Important Medication-Related Tips for the Parkinson’s Disease Patient
Are Blood Tests for Parkinson’s Disease on the Horizon?
Placing Stem Cells in Animal Models of Parkinson’s Disease: Another Important Step
Important News for the Parkinson’s Disease Community: More Evidence that Sinemet and Madopar are Not Toxic and do Not Accelerate Disease Progression
The Case for All Parkinson’s Disease Patients to be Co-managed by a Primary Care-Neurologist Team
Scientists say Research on Brain Proteins Involved in Parkinson’s Disease is “Shaping” Up
Who Actually Takes Care of Most of the Parkinson’s Patients Worldwide: The Need for Education and the Parkinson’s Toolkit
If you are Dizzy or Passing Out, it could be Your Parkinson’s Disease or Parkinson’s Disease Medications
How Will Group Visits for Parkinson’s Disease Fit into the Future of Parkinson’s Disease Care?
Why Patients Should be Wary of Chelation Therapy for Parkinson’s Disease
Opening the Door to Gene Therapy in Parkinson’s Disease: The Need for Refinement of the Technology and Approach
Does it Matter if I Can’t Get Brand Sinemet?
Should I get a DaTscan or PET scan to confirm my diagnosis of Parkinson’s disease?
A Critical Reappraisal of the Worst Drugs in Parkinson’s Disease
Environmental Risks for PD: Manganese, Welding, Mining, and Parkinsonism
Calling for the FDA to Revise the Eight Sinemet a Day Rule
Dry Cleaning Solvents and Potential Environmental Risks for Developing Parkinson’s Disease
Maintaining the Balance: Why Parkinson’s Disease Patients Need to Understand Drug Recalls, Withdrawals, and Safety Alerts
Shining a Light on Parkinson’s Disease: Optogenetics Has a Bright Future in Research
Poor Medication Management of Parkinson's Disease During Hospital Admissions: Patients and Families Can Improve Their Hospital-Based Management
Why Are Patches and Continuous Release Technology a Big Deal to Parkinson's?
Is the PD SURG Trial Another Surge Forward for DBS Therapy?
Cycling in PD in Those Who Can’t Walk: Is it Possible?
New iPS Stem Cells for PD: What Does it Mean?
Time for Comprehensive Care Networks for PD
Is Parkinson's Disease a Prion Disease?
Parkinson's Disease Linked to Gaucher's Disease
Brain Cells Keep Time Stamps: Implications for Parkinson's Disease Therapies
Is it Safe to Have an MRI with a DBS in Place?
Take Care of Your Bones as They Are Affected in Parkinson's Disease (Even in Men)
Is it Time to Start Paying Attention to Pain Symptoms in Parkinson's Disease Patients?
Glutathione Fails to Demonstrate Significant Improvement in PD Symptoms
Keeping an Eye on Trials Important to the Parkinson's Disease Patient
Increased Risk of Melanoma in Parkinson's Disease
Finally a DBS Expert Consensus Statement Aimed at Their True Customers: The Patients
Pesticides and Environmental Exposure in Parkinson's disease: Should We Stay Away From the Stink Truck?
Is Exercise Effective Treatment and Protection Against PD?
Why are Transplant Trials Struggling to Succeed in the Treatment of PD?
Are Monoamine Oxidase Inhibitors Disease Modifying or Neuroprotective in PD?
Update on Gene Therapy for Parkinson's Disease