2.1. Study Design, Subjects, and Randomization
PSH
DISEASE, RECRUITMENT
This study was conducted at PennStateHealth (PSH) in compliance with the Declaration of Helsinki and guidelines for Good Clinical Practice issued by the International Conference on Harmonization. It was reviewed and approved by the US Food and Drug Administration and PSH Institutional Review Board. All participants and caregivers provided signed informed consent. Details of subject recruitment, inclusion and exclusion criteria, baseline medical, protocol information, and safety data were published in a previous report [All LsPD subjects had disease duration >15 y and Hoehn and Yahr (HY) stages ≥IV, either “on” or “off” levodopa. Our criteria adapted the terminology of Coelho and Ferreira [Eligible participants were randomized to PF-2562 (Sequence A) or levodopa (Sequence B) during Test Period 1 using a 1:1 random allocation sequence and then crossed over to the other drug during Test Period 2 (