Safety of Urate Elevation in Parkinson's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT00833690

Run by

The Parkinson Study Group

People needed

75

Starts

2009-06-01

Expected to finish

2012-12-01

Last updated by the study team

2014-06-05

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Eastern Connecticut Neurology Specialists, LLC — Manchester, Connecticut, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Michigan State University — East Lansing, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Butler Hospital Movement Disorder Program — Providence, Rhode Island, United States
• Scott & White Hospital — Temple, Texas, United States
• University of Southern California — Los Angeles, California, United States
• Eastern Connecticut Neurology Specialists, LLC — Manchester, Connecticut, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Michigan State University — East Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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