Both trials were conducted at PSG sites. The PSG is an independent consortium of scientific investigators committed to the cooperative planning, implementation, analysis, and reporting of controlled clinical trials and other research in PD and related disorders.
STEADY-PD III was a phase 3, randomized, 2-arm, parallel-group, placebo-controlled, double-blind, multicenter clinical trial designed to assess the disease-modifying potential of isradipine in patients with early PD not receiving or requiring symptomatic therapy at baseline other than a stable dose of amantadine or anticholinergics. Participants were randomized 1:1 to receive either isradipine 5 mg twice daily or placebo for 36 months. Northwestern University served as the Clinical Coordination Center (CCC); the University of Rochester Clinical Trials Coordination Center served as the Data Coordination Center (DCC).8 (link) Inclusion criteria included age greater than 30 years, a PD diagnosis made within 3 years of screening, and not receiving excluded symptomatic PD therapy.9 (link) Exclusion criteria included history of significant cardiovascular disease, unstable medical or psychiatric conditions, significant cognitive impairment, use of calcium channel blockers, or other use of antihypertensives that would make exposure to isradipine unsafe.
SURE-PD3 was a phase 3, randomized, 2-arm, parallel-group, placebo-controlled, double-blind, 2-period, multicenter clinical trial designed to assess the disease-modifying potential of inosine in patients with early PD not receiving or requiring symptomatic therapy at baseline other than a stable dose of a monoamine oxidase–B inhibitor. Participants were randomized 1:1 to receive either oral inosine titrated to achieve a serum urate level from 7.1 to 8.0 mg/dL or placebo for 24 months. Massachusetts General Hospital served as the CCC; the University of Rochester served as the DCC.10 (link) Inclusion criteria included age greater than 30 years, a PD diagnosis made within 3 years of the screening visit, not receiving excluded symptomatic PD therapy, and serum urate ≤5.7 mg/dL. Exclusion criteria included history of significant cardiovascular disease, unstable medical or psychiatric conditions, significant cognitive impairment, use of thiazide diuretics, and history of crystallopathy or increased risk of crystallopathy due to low urine pH or renal impairment.
STEADY-PD III was a phase 3, randomized, 2-arm, parallel-group, placebo-controlled, double-blind, multicenter clinical trial designed to assess the disease-modifying potential of isradipine in patients with early PD not receiving or requiring symptomatic therapy at baseline other than a stable dose of amantadine or anticholinergics. Participants were randomized 1:1 to receive either isradipine 5 mg twice daily or placebo for 36 months. Northwestern University served as the Clinical Coordination Center (CCC); the University of Rochester Clinical Trials Coordination Center served as the Data Coordination Center (DCC).8 (link) Inclusion criteria included age greater than 30 years, a PD diagnosis made within 3 years of screening, and not receiving excluded symptomatic PD therapy.9 (link) Exclusion criteria included history of significant cardiovascular disease, unstable medical or psychiatric conditions, significant cognitive impairment, use of calcium channel blockers, or other use of antihypertensives that would make exposure to isradipine unsafe.
SURE-PD3 was a phase 3, randomized, 2-arm, parallel-group, placebo-controlled, double-blind, 2-period, multicenter clinical trial designed to assess the disease-modifying potential of inosine in patients with early PD not receiving or requiring symptomatic therapy at baseline other than a stable dose of a monoamine oxidase–B inhibitor. Participants were randomized 1:1 to receive either oral inosine titrated to achieve a serum urate level from 7.1 to 8.0 mg/dL or placebo for 24 months. Massachusetts General Hospital served as the CCC; the University of Rochester served as the DCC.10 (link) Inclusion criteria included age greater than 30 years, a PD diagnosis made within 3 years of the screening visit, not receiving excluded symptomatic PD therapy, and serum urate ≤5.7 mg/dL. Exclusion criteria included history of significant cardiovascular disease, unstable medical or psychiatric conditions, significant cognitive impairment, use of thiazide diuretics, and history of crystallopathy or increased risk of crystallopathy due to low urine pH or renal impairment.
