Table 13Goal Attainment Scaling Total Score at 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)

GAS score at week 4
 n (%)78 (99)79 (100)76 (99)
 Mean (SD)50.4 (10.1)49.8 (11.1)45.5 (10.4)
LS mean (95% CI)51.53 (49.05 to 54.01)50.86 (48.36 to 53.36)46.21 (43.70 to 48.72)
Comparison with placebo
 Difference in LS mean (95% CI)5.32 (2.31 to 8.32)4.65 (1.59 to 7.71)NA
P value0.00060.0031NA

aboBoNTA = abobotulinumtoxinA; ANOVA = analysis of variance; BoNT = botulinum toxin; CI = confidence interval; GAS = goal attainment scaling; ITT = intention-to-treat; LS = least squares; N = number of patients in group; n = number of patients with data; NA = not applicable; SD = standard deviation; U = unit.

Note: LS means for each treatment group and treatment comparisons, as well as the P values, are obtained from an ANOVA on the visit value with treatment, age range at baseline, and BoNT status at baseline and at centre as covariates.

Source: Study 141 Clinical Study Report.22

From: Results

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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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