Status:
COMPLETED
Safety of Urate Elevation in Parkinson's Disease
Lead Sponsor:
The Parkinson Study Group
Collaborating Sponsors:
Massachusetts General Hospital
Harvard School of Public Health (HSPH)
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and tolerability of inosine and its ability to raise urate levels in blood and cerebral spinal fluid in individuals with early Parkinson disease. T...
Detailed Description
Background \& Rationale: Convergent epidemiological and clinical observations have identified urate - a major antioxidant and the end product of purine metabolism in humans - as the first molecular p...
Eligibility Criteria
Inclusion
- Idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity)
- Currently not taking or needing any treatment for PD other than an monoamine oxidase-B (MAO-B) inhibitor
- Age 30 or older at the time of PD diagnosis
- Diagnosis of PD made within past 3 years
- Serum urate ≤ 5.8 mg/dL at initial screening
Exclusion
- History of kidney stones, gout, stroke, or heart attack
- History of renal disease or certain cardiovascular problems within the past year
- Acidic urine (pH ≤ 5.0), uric acid, or urate crystalluria at screening
- Use of certain medications including co-enzyme Q, creatine, more than 50 IU of vitamin E daily, and more than 300 mg of vitamin C daily. (A standard daily multivitamin is permitted.)
- Use of anti-PD and other medications targeting central nervous system dopamine transmission
- Known unstable medical or psychiatric condition that may compromise participation in the study
- Women who are pregnant or lactating
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00833690
Start Date
June 1 2009
End Date
December 1 2012
Last Update
June 5 2014
Active Locations (16)
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1
University of Southern California
Los Angeles, California, United States, 90083
2
Eastern Connecticut Neurology Specialists, LLC
Manchester, Connecticut, United States, 06040
3
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
4
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486