Table 29Lower-Limb Pain — Faces Pain Scale, Change From Baseline (Dose per Leg) for Study 141 (ITT Population)

AboBoNTA 10 U/kg/leg

(N = 79)

AboBoNTA 15 U/kg/leg

(N = 79)

Placebo

(N = 77)

At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
At Week 4
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 4
 n (%)▬▬▬
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
At Week 12
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
At Week 16
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 16
 n (%)▬▬▬
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
At Week 22
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
At end of study
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 22
 n (%)▬▬▬
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬

aboBoNTA = abobotulinumtoxinA; BoNT = botulinum toxin; Cl = confidence interval LS = least squares; SD = standard deviation.

▬▬▬▬▬

Source: Study 141 Clinical Study Report.22

From: Appendix 4, Detailed Outcome Data

Cover of Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic)
Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet].
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