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Sponsors and Collaborators: |
University of Rochester National Institute of Neurological Disorders and Stroke (NINDS) |
Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00449865 |
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
Condition | Intervention | Phase |
Parkinson's Disease |
Drug: creatine Other: placebo |
Phase III |
Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
MedlinePlus related topics: | Parkinson's Disease |
Drug Information available for: | Creatine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 1720 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2014 |
Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Other: placebo
an inactive substance
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2: Active Comparator
creatine
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Drug: 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. |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Irenita Gardiner | 585-341-7569 | nita.gardiner@ctcc.rochester.edu |
Contact: Ann Stoutenburg | 585-275-7311 | ann.stoutenburg@ctcc.rochester.edu |
Show 50 Study Locations |
University of Rochester |
National Institute of Neurological Disorders and Stroke (NINDS) |
Principal Investigator: | Karl Kieburtz, MD | Coordination Center |
Principal Investigator: | Barbara Tilley, PhD | Statistics Center |
NET PD website 
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Responsible Party: | University of Rochester ( Karl Kieburtz, MD, MPH, Clinical Trials Coordination Center ) |
Study ID Numbers: | U01NS43128 NET-PD, CRC |
First Received: | March 20, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00449865 |
Health Authority: | United States: Food and Drug Administration |
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