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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]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Aug.

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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Table 24Goal Attainment Scaling Total Score at all Time Points (Except Week 4) (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)

Week 12
 n (%)
 Mean change (SD)
 LS mean change (95% CI)
 LS mean change vs. placebo (95% CI)
P value
Week 16
 n (%)
 Mean change (SD)
 LS mean change (95% CI)
 LS mean change vs. placebo (95% CI)
Week 22
 n (%)
 Mean change (SD)
 LS mean change (95% CI)
 LS mean change vs. placebo (95% CI)
Week 28a
 n (%)
 Mean change (SD)

aboBoNTA = abobotulinumtoxinA; ANOVA = analysis of variance; BoNT = botulinum toxin; Cl = confidence interval; ITT = intention-to-treat; LS = least squares; N = number of patients in group; n = number of patients with data; SD = standard deviation; U = unit; vs. = versus.

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Source: Study 141 Clinical Study Report.22

From: Appendix 4, Detailed Outcome Data

Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

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