Table 19Modified Ashworth Scale Score in the (Most) Affected Leg, Change From Baseline at Week 4, by Botulinum Toxin Status and Treatment Group (Dose per Leg) for Study 141 — ITT Population

AboBoNTA10 U/kg/leg

(N = 79)

AboBoNTA15 U/kg/leg

(N = 79)

Placebo

(N = 77)

Botulinum toxin status = naive
 N (%)▬▬▬
MAS score at baseline
 Mean (SD)▬▬▬
MAS score at week 4
 Mean (SD)▬▬▬
Change in MAS score from baseline to week 4
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Botulinum toxin status = experienced
 N (%)▬▬▬
MAS score at baseline
 Mean (SD)▬▬▬
MAS score at week 4
 Mean (SD)▬▬▬
Change in MAS score from baseline to week 4
 Mean (SD)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬

aboBoNTA = abobotulinumtoxinA; BoNT = botulinum toxin; CI = confidence interval; ITT = intention-to-treat; LS = least squares; MAS = Modified Ashworth Scale; N = number of patients in group; SD = standard deviation; U = unit.

▬▬▬▬▬

Source: Study 141 Clinical Study Report.22

From: Appendix 4, Detailed Outcome Data

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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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