Table 21Tardieu Scale: Angle of Arrest and Angle of Catch in the (Most) Affected Leg, Change From Baseline at all Time Points (Dose per Leg) — ITT Population

AboBoNTA 10 U/kg/leg

(N = 79)

AboBoNTA 15 U/kg/leg

(N = 79)

Placebo

(N = 77)

Angle of arrest (XV1) in degrees
Baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Week 4
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Week 12
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Week 16
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Week 22
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Angle of catch (XV3) in degrees
Baseline
 N (%)▬▬▬
 Mean (SD)▬▬▬
Week 4
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Week 12
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Week 16
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬
Week 22
 n (%)▬▬▬
 LS mean change (95% CI)▬▬▬
 LS mean change versus placebo (95% CI)▬▬▬
 P value▬▬▬

aboBoNTA = abobotulinumtoxinA; ANCOVA = analysis of covariance; BoNT = botulinum toxin; CI = confidence interval; ITT = intention-to-treat; LS = least squares; MAS = Modified Ashworth Scale; N = number of patients in group; n = number of patients with data; NA = not applicable; 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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