Table 2.
Muscle group | AboBoNT‐A 1000 U N = 30 | AboBoNT‐A 1500 U N = 28 | ||
---|---|---|---|---|
n | Mean (SD) Median [range] dose, U | n | Mean (SD) Median [range] dose, U | |
All sites | 30 | 993.3 (26.8) 1000 [867‐1000] | 28 | 1469.3 (132.9) 1500 [800‐1500] |
Lateral gastrocnemius | 22 | 88.8 (29.6) 93 [67‐200] | 26 | 128.8 (25.3) 150 [100‐160] |
Medial gastrocnemius | 30 | 141.6 (41.3) 133 [100‐200] | 28 | 169.6 (47.9) 150 [0‐300] |
Flexor digitorum longus | 23 | 139.1 (44.6) 133 [67‐267] | 23 | 221.7 (67.1) 200 [100‐300] |
Soleus | 30 | 333.3 (0.0) 333 [333‐333] | 28 | 478.6 (95.7) 500 [0‐500] |
Tibialis posterior | 20 | 190.0 (92.5) 200 [67‐467] | 19 | 274.7 (111.5) 200 [180‐600] |
Flexor digitorum brevis | 5 | 77.3 (31.8) 67 [53‐133] | 8 | 137.5 (74.4) 100 [100‐300] |
Flexor hallucis brevis | 3 | 111.1 (38.5) 133 [67‐133] | 1 | 160.0 (−) 160 [160‐160] |
Flexor hallucis longus | 17 | 94.9 (33.3) 67 [67‐133] | 15 | 164.0 (47.9) 200 [100‐200] |
Adductor magnus | N/A | N/A | 1 | 300.0 (−) 300 [300‐300] |
Hamstrings | 4 | 183.3 (63.8) 167 [133‐267] | 4 | 300.0 (81.6) 300 [200‐400] |
Rectus femoris | 19 | 186.0 (61.2) 200 [67‐267] | 11 | 372.7 (142.1) 400 [200‐700] |
Gluteus maximus | N/A | N/A | N/A | N/A |
Gracilis | N/A | N/A | N/A | N/A |
AboBoNT‐A, abobotulinumtoxinA; n, number of patients who received an injection in the associated muscle group; N/A, not applicable.
Data are presented for the safety population. The study protocol required that the total injection volume (7.5 mL) was divided between the soleus muscle (exactly 2.5 mL); the medial and/or lateral gastrocnemius muscle (exactly 1.5 mL); and at least one other lower limb muscle selected by the investigator (the remaining injection volume 3.5 mL split between investigator selected sites).