Outcome

Visit 1

Visit 2

P Value

Mean ± STD (Range) or N (%)

Mean ± STD

(Range) or N (%)

MDS-UPDRS, Part III

Summary Score

28.9 ± 14.1 (6 - 67)

24.1 ± 13.5 (6 - 61)

0.028*

Score > 27 [30]

15 (54%)

12 (43%)

MDS-UPDRS, Part IV

Summary Score

4.1 ± 3.3 (0 - 16)

3.0 ± 2.9 (0 - 9)

0.07*

Dyskinesias

5 (18%)

5 (18%)

Functional Impact Moderate or Severe

1 (20%)

0 (0%)

Motor fluctuations

23 (82%)

21 (75%)

>50% time spent in off state

10 (44%)

4 (19%)

Complexity Moderate or Severe

4 (17%)

0 (0%)

PKG Scores [All Patients]

Total Scores (Mean± SD; Range)

BKS

DKS

FDS

PTI (%)

PTT (%)

Hoehn and Yahr Scale

[Controlled Bradykinesia (BKS ≤ 25)]

BKS

DKS

FDS

PTI (%)

PTT (%)

[Uncontrolled (BKS > 25)]

BKS

DKS

FDS

PTI (%)

PTT (%)

[Uncontrolled Dyskinesia (DKS > 9)]

[Other]

FDS > 13 [30] [31]

PTI > 5% [16]

PTT >1% [17]

31.7 ± 7.1 (20.2 - 51.1)

1.8 ± 2.2 (0.0 - 7.2)

8.0 ± 2.6 (3.3 - 15.4)

12.6 ± 9.7 (0 - 42.4)

12.5 ± 11.9 (0.7 - 44.3)

1.79

6 (21%)

22.5 (20.2 - 25.0)

4.5 (1.0 - 7.2)

9.1 (3.3 - 15.4)

2.2 (0.0 - 6.4)

9.9 (0.7 - 23.4)

22 (79%)

34.2 (25.4 - 51.1)

1.1 (0 - 6.9)

7.7 (4.8 - 13.2)

15.5 (1.1 - 42.4)

13.3 (0.7 - 44.3)

0 (0%)

2 (7%)

23 (82%)

23 (82%)

31.6 ± 7.0 (20.5 - 52.3)

1.5 ± 1.6 (0.0 - 8.0)

8.1 ± 2.2 (4.3 - 13.4)

12.8 ± 8.3 (1.1 - 33.5)

12.2 ± 12.1 (0.2 - 44.6)

1.82

5 (18%)

22.5 (20.5 - 24.9)

3.3 (1.2 - 8.0)

9.3 (4.3 - 13.4)

4.9 (2.3 - 9.6)

3.9 (0.2 - 10.8)

23 (82%)

33.6 (26.7 - 52.3)

1.1 (0 - 2.9)

7.8 (4.4 - 11.1)

14.5 (1.1 - 33.5)

14.1 (0.8 - 44.6)

0 (0%)

1 (4%)

20 (71%)

26 (93%)

0.86

0.21

0.82

0.88

0.78

0.76