NET-PD LS-1 Creatine in Parkinson's Disease
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- using a global statistical test this study will compare disease progression at 5 years between the creatine and placebo groups. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]
- comparison of creatine and placebo groups on efficacy, safety and tolerability between baseline and 5 years of follow-up. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
an inactive substance
Active Comparator: 2
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.
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.
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|Principal Investigator:||Karl Kieburtz, MD||Coordination Center|
|Principal Investigator:||Barbara Tilley, PhD||Statistics Center|