Table 1. Optimization of BoNT-A parameters over the study treatment course for PD participants.
ID | Week 0 (First Injection) | Week 16 (Second Injection) | Week 32 (Third Injection) | Week 48 (Fourth Injection) | Week 64 (Fifth Injection) | Week 80 (Sixth Injection) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
BoNT-A Dose (U) | No. of Muscles Injected | Event | BoNT-A Dose (U) | No. of Muscles Injected | Event | BoNT-A Dose (U) | No. of Muscles Injected | Event | BoNT-A Dose (U) | No. of Muscles Injected | Event | BoNT-A Dose (U) | No. of Muscles Injected | Event | BoNT-A Dose (U) | No. of Muscles Injected | |
1 | 100 | 7 | G | D,M | 75 | 8 | D,D(M) | 100 | 7 | N | 100 | 7 | N | 100 | 7 | ||
2 | 200 | 7 | N | 200 | 7 | G | N | 200 | 7 | I,M | 300 | 13 | N | 300 | 13 | ||
3 | 100 | 6 | N | 100 | 6 | G | N | 100 | 6 | N | 100 | 6 | N | 100 | 6 | ||
4 | 100 | 8 | I | 200 | 8 | G | D | 170 | 8 | N | 170 | 8 | I | 200 | 8 | ||
5 | 100 | 8 | N | 100 | 8 | G | N | 100 | 8 | I,M | 160 | 9 | I | 195 | 9 | ||
6 | 100 | 6 | WD2 | ||||||||||||||
7 | 200 | 8 | G | N | 200 | 8 | N | 200 | 8 | N | 200 | 8 | G | ||||
8 | 275 | 8 | WD2 | ||||||||||||||
9 | 260 | 9 | I,M | 390 | 11 | G | WD3 | ||||||||||
10 | 125 | 7 | G | N | 125 | 7 | D | 100 | 7 | N | 100 | 7 | D | 85 | 7 | ||
11 | 140 | 8 | I,M | 175 | 9 | G | WD3 | ||||||||||
12 | 100 | 8 | I | 170 | 8 | D | 100 | 8 | I | 170 | 8 | N | 170 | 8 | N | 170 | 8 |
13 | 175 | 8 | N | 175 | 8 | D | 135 | 8 | I | 175 | 8 | N | 175 | 8 | WD4 | ||
14 | 95 | 7 | N | 95 | 7 | N | 95 | 7 | N | 95 | 7 | N | 95 | 7 | N | 95 | 7 |
15 | 320 | 11 | I,M | 350 | 11 | WD2 | |||||||||||
16 | 200 | 11 | WD1 | ||||||||||||||
17 | 200 | 11 | I,D(M) | 280 | 9 | I,D(M) | 300 | 8 | N | 300 | 8 | WD4 | |||||
18 | 200 | 10 | N | 200 | 10 | N | 200 | 10 | N | 200 | 10 | N/A | N | 200 | 10 | ||
19 | 200 | 6 | WD2 | ||||||||||||||
20 | 265 | 13 | I | 300 | 13 | N | 300 | 13 | D | 290 | 13 | N | 290 | 13 | N | 290 | 13 |
21 | 200 | 8 | I,M | 280 | 12 | I,M | 300 | 13 | WD3 | ||||||||
22 | 200 | 8 | D | 100 | 8 | N | 100 | 8 | N | 100 | 8 | N | 100 | 8 | N | 100 | 8 |
23 | 190 | 11 | D | 100 | 11 | N | 170 | 11 | N | 170 | 11 | N | 170 | 11 | N | 170 | 11 |
24 | 200 | 8 | I | 200 | 8 | M | 200 | 11 | N | 200 | 11 | N | 200 | 11 | N | 200 | 11 |
25 | 300 | 12 | D(M) | 300 | 12 | M | 300 | 12 | N | 300 | 12 | N | 300 | 12 | N | 300 | 12 |
26 | 100 | 7 | I,M | 200 | 9 | WD1 | |||||||||||
27 | 130 | 9 | I,M | 200 | 11 | N | 200 | 11 | N | 200 | 11 | N | 200 | 11 | N | 200 | 11 |
28 | 100 | 6 | D | 80 | 6 | WD4 | |||||||||||
Mean | 174.1 | 8.4 | 199.8 | 9.1 | 186.7 | 9.5 | 176.1 | 8.8 | 176.9 | 9.2 | 180.3 | 9.4 | |||||
SD | 68.0 | 1.9 | 89.2 | 2.0 | 82.3 | 2.1 | 69.5 | 2.0 | 70.9 | 2.3 | 74.8 | 2.3 | |||||
Median | 195.0 | 8.0 | 200.0 | 9.0 | 200.0 | 8.0 | 172.5 | 8.0 | 170.0 | 8.0 | 195.0 | 9.0 | |||||
Range min | 95.0 | 6.0 | 75.0 | 6.0 | 75.0 | 8.0 | 95.0 | 6.0 | 95.0 | 6.0 | 85.0 | 6.0 | |||||
Range max | 320.0 | 13.0 | 350.0 | 13.0 | 300.0 | 13.0 | 300.0 | 13.0 | 300.0 | 13.0 | 300.0 | 13.0 |
Abbreviations: M: Number of muscles increased; D(M): Number of muscles decreased; G: Participant had minimal tremor at visit and injector made clinical judgement to not inject; N: No change to parameters; D: decreased total dose; I: Increased total dose; N/A: Missed visit; WD1: Withdrawn due to lack of time commitment; WD2: Withdrawn due to unwanted weakness perceived my participant; WD3: Withdrawn due to participant perceiving no benefit; WD4: Withdrawn due to other health symptoms arose.