Safety of Urate Elevation in Parkinson's Disease

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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. This will determine whether it is appropriate to proceed with a larger study of inosine's ability to modify the rate of disability progression in PD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Parkinson Study Group
• Collaborators: Harvard School of Public Health; Harvard School of Public Health (HSPH); Massachusetts General Hospital; Michael J. Fox Foundation for Parkinson's Research; University of Rochester
• Treatments: Uric Acid

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