Study of Urate Elevation in Parkinson's Disease, Phase 3 (SURE-PD3)
Purpose: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD.
Study design: Randomized, Double-Blind, Placebo-Controlled
Study duration: Up to 27 months
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease
Age 30 or older at the time of PD diagnosis.
Diagnosis of PD made within 3 years prior to 1st Screening Visit.
History of gout.
History of uric acid or urate urolithiasis, or recurrent urolithiasis all of unknown type.
History of myocardial infarction or stroke.
History of severe chronic obstructive pulmonary disease.
Use of any anti-parkinsonian medication other than monoamine oxidase-B inhibitors within 60 days of Baseline, or in excess of 90 days.
Unstable dosing of a thiazide -- such as hydrochlorothiazide
Known unstable medical or psychiatric condition that may compromise participation in the study. (Note that difficulty swallowing large capsules might preclude participation due to the size of the study drug capsules.)
Known hypersensitivity or intolerability to inosine.