Status:
TERMINATED
NET-PD LS-1 Creatine in Parkinson's Disease
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent and willing to commit to long-term follow-up
- PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis
- Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years.
Exclusion
- Use of creatine 14 days prior to baseline or during the study
- History of known hypersensitivity or intolerability to creatine
- Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up
- Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
1741 Patients enrolled
Trial Details
Trial ID
NCT00449865
Start Date
March 1 2007
End Date
May 1 2014
Last Update
April 2 2015
Active Locations (50)
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1
University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
Birmingham, Alabama, United States, 35233
2
Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
Phoenix, Arizona, United States, 85013
3
Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
Fountain Valley, California, United States, 92708
4
University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
Los Angeles, California, United States, 90033