NET-PD LS-1 Creatine in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00449865|
Recruitment Status : Terminated (Futility)
First Posted : March 21, 2007
Results First Posted : April 2, 2015
Last Update Posted : April 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: creatine Other: placebo||Phase 3|
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.
This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1741 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||May 2014|
|Placebo Comparator: Placebo||
an inactive substance
|Active Comparator: creatine||
Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
The study is comparing creatine 5 grams twice daily with placebo.
- The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years. [ Time Frame: Change from baseline to 5 YEARS ]All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449865
|Principal Investigator:||Karl Kieburtz, MD||Coordination Center|
|Principal Investigator:||Barbara Tilley, PhD||Statistics Center|