Table 1 Overview on clinical assessments for each study visit
time (months) | visit | clinical assessments |
|---|---|---|
−3-0 | screening | MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA informed consent check of inclusion/exclusion criteria |
0 | start visit | MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA MRI/MRSI |
1 | phone call 1 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
2 | phone call 2 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
3 | visit 1 | MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA |
4 | phone call 3 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
5 | phone call 4 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
6 | visit 2 (end of study treatment) | MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA MRI/MRSI |
9 | follow-up visit | MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA MRI/MRSI |