Date of consent or enrollment | Observation period (week) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 1a | 4 | 8 | 12 | 16 | 20 | 24 | 28 | 32 | 36b | 37c | ||
Informed consent | ● | ||||||||||||
Eligibility confirmation | ● | ● | |||||||||||
MMSE | ● | ||||||||||||
Patient background | ● | ||||||||||||
Medical history/complications | ● | ||||||||||||
Decision on dose increase of levodopa-containing medications | ● | ● | ● | ● | ● | ● | ● | ● | ● | ||||
CGI-S | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |||
CGI-I | ● | ● | ● | ● | ● | ● | ● | ● | ● | ||||
PGI-S | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |||
PGI-I | ● | ● | ● | ● | ● | ● | ● | ● | ● | ||||
mH&Y (ON/OFF) | ● | ● | ● | ● | |||||||||
MDS-UPDRS (part I, II, III, IV) | ● | ● | ● | ● | |||||||||
PDQ-39 | ● | ● | ● | ● | |||||||||
Wearable device data | ● | ● | ● | ●e | |||||||||
Symptom diaryd | ● | ● | ● | ●e | |||||||||
Hospitalizations | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
Concomitant medication check | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
Adverse events | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
Information on discontinuation | At any time | ||||||||||||
Data entry into the case report form | Within 2 weeks after each visit |