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.
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Purpose: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.
Study design: Randomized, Double-Blind, Placebo Controlled
Study duration: Approximately 23 weeks
Official title: A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Flexible Dose Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Early Stage Parkinson's Disease
45 years to 80 years
Females of non-childbearing potential and/or male subjects
Clinical diagnosis of Parkinson's disease.
Able to refrain from any Parkinson's disease medication not permitted by the protocol.
History or presence of atypical Parkinsonian syndrome.
Severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality.
Any condition possibly affecting drug absorption.