Safety of Urate Elevation in Parkinson's Disease (SURE-PD)
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Parkinson disease, PD, inosine, urate, uric acid, cerebrospinal fluid
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Southern California
- Eastern Connecticut Neurology Specialists, LLC
- Institute for Neurodegenerative Disorders
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Rush University Medical Center
- Ochsner Clinic Foundation
- Massachusetts General Hospital
- Boston University Medical Center
- Michigan State University
- Struthers Parkinson's Center
- Duke University School of Medicine
- University of Cincinnati
- Cleveland Clinic
- Oregon Health and Science University
- Butler Hospital Movement Disorder Program
- Scott & White Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
[A:]
[B:]
[C.]
Placebo to produce no urate elevation
Inosine to produce a mild urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL
Inosine to produce a moderate urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL