Study design and participants
PD, ; mouth, idiopathic PD
DISORDER, SECONDARY PARKINSONISM
This multicenter, open-label, randomized, crossover study assessed SL-APO compared with SC-APO in patients with PD and OFF episodes and was conducted in Europe (EudraCT: 2016-003456-7). Herein we provide a brief review of methods, with full methodology available in the Supplementary Methods. Eligible patients were ≥18 years of age with idiopathic PD responsive to and being treated with stable doses of CD/LD and any additional PD medications for ≥4 weeks (>8 weeks for monoamine oxidase-B inhibitors), were stage 1–3 by modified Hoehn and Yahr scale when ON, had ≥1 OFF episode/day and ≥2 h of total daily OFF time, and had a Mini-Mental State Examination score >25. Key exclusion criteria included atypical or secondary parkinsonism; major psychiatric disorder; mouth cankers/sores; prior device-aided treatments; permanent discontinuation of prior SC-APO administration or prior exposure to SL-APO; currently taking selective 5-HTThe study was designed, conducted, and monitored in accordance with the World Medical Association Declaration of Helsinki (1989) and International Council for Harmonisation guidelines. The study protocol and study procedures were approved by institutional review boards and independent ethics committees at each study site (Supplementary Methods).