Table 3 Overview of study assessments

Primary efficacy endpoint

Change from baseline in Domain 3 (fluctuation-related pain) of KPPS

Key secondary endpoint

Change from baseline in Domain B (anxiety) of MDS-NMS

Additional secondary endpoints

Change from baseline in Domain A (depression) of MDS-NMS

Change from baseline in Domain K (sleep and wakefulness) of MDS-NMS

Change from baseline in MDS-NMS total score

Change from baseline in Domain 4 (nocturnal pain) of KPPS

Change from baseline in KPPS total score

Change from baseline in MDS-UPDRS Parts III and IV

Change from baseline in PDQ-8

CGI-C

PGI-C

Change from baseline in functional status via Hauser’s PD diary

Changes from baseline in morning dystonia

Use of rescue medication^a

Safety assessments

Incidence of TEAEs, including serious TEAEs

Changes from baseline in vital signs

Changes from baseline in physical and neurological examinations

Changes from baseline in routine laboratory parameters^b